msl recommendation recommendation_2017 japhmed_en.pdf · (ktl/kol engagement, etc.) medical...

MSL Recommendation

MSL Recommendation Task Force Team in Medical

Affairs Committee of JAPhMed

Contents

About JAPhMed and the history for the preparation of MSL

Recommendation

Japanese Association of Pharmaceutical Medicine

MSL Accreditation

MSL recommendation task force

MA Definition and Role

MSL Definition

Activities of MSL

Regulation MSL should consider

Recommended KPI for MSL

Requirement of MSL

Training Outline

How to develop MSL training curriculum

MSL training curriculum (specifics)

JAPhMed: History

Association of Medical

Doctors (MD Association)

organized in 1967

Association of Pharmaceutical

Medical Doctors (PMD Association)

organized in 1968

Integrated to JAMDI

(Japanese Association of Medical Doctors in Drug Industries),

held the first meeting in 1969.

JAPhMed as Legal Entity in 2002

(Japanese Association of Pharmaceutical Medicine)

IFAPP established

in 1975

Open the door to non-MD members

Developed Clinical Research Guideline in collaboration with another medical society

Developed Contract Sample for Investigator sponsored Research in collaboration with a legal society

Announced Proposal on Medical Advisory Board meeting

Survey

2011, 2013, 2015 MSL Survey

2012, 2016 Medical Affairs Survey

2015 Survey on Clinical Research

Accreditation of MSL Certification Program

1st Accreditation for a corporate MSL certification program in May, 20152nd Accreditation for a corporate MSL certification program in February, 2017

Recent Activities of JAPhMed on Medical Affairs

About Accreditation of MSL Certification

Program

Third-party accreditation of medical science liaison (MSL)

certification programs of individual companies by the Japanese

Association of Pharmaceutical Medicine (JAPhMed).

For accreditation of the programs, evaluation standards have

been established to verify independence of MSL from

promotional activities by Sales and Marketing Division and to

ensure contribution to the advancement of healthcare based on

an advanced level of medical and scientific expertise.

Source: MSL Recommendations Interim Report , 2016

JAPhMed Annual Meetinghttp://japhmed.jp/msl/msl.html

Accreditation Standards

for MSL Certification Program

- Evaluation Standards/Evaluation Items -

MSL certification programs are reviewed by the reviewers

commissioned by JAPhMed in accordance with the

“Accreditation Standards for MSL Certification Programmes”

(December 1st, 2014).

Evaluation domains are as follows:

1. Independence from promotional activities

(compliance structure)

2. Medical and scientific expertise

3. Educational system

Source: MSL Recommendations Interim Report , 2016

JAPhMed Annual Meetinghttp://japhmed.jp/msl/msl.html

Overview of Accreditation of

MSL Certification Program

JAPhMedPharmaceutical

companies

Society

Secretariat

Medical Affairs (MA) Committee

MSL Accreditation Standards

Committee

Medical Safety (MS) Committee

Certification Committee in

Pharmaceutical Medicine

Kansai

Committee

Education

Committee

Board of DirectorsCouncilCorporate

program to

certify MSL

(individual)

MSL

(individual)

Revie

w C

om

mit

tee

Application

Accreditation

Commis-

sion

Review

Report

Ce

rtif

ica

tio

n

http://japhmed.jp/msl/msl.html

MSL Recommendation Task Force Team

JAPhMed MA Committee

Set up the Task Force Team by the Appointed and

the Interested members

17 pharmaceutical companies

23 members

Source: MSL Recommendations Interim Report ,

2016 & 2017 JAPhMed Annual Meeting

Since Accreditation of MSL Certification Program was opened, ,

JAPhMed has received many inquiries about individual MSL training,

roles, KPI, requirement etc.

Definition of Medical Affairs (MA)

http://japhmed.jp/

A division independent of the divisions in charge of sales and marketing

of products, and is responsible for generating and providing necessary

information to healthcare professionals including physicians and

optimizing medical value of the company products based on medical or

scientific knowledge.

Source: MSL Recommendations Interim Report, 2016 JAPhMed Annual Meeting (partially modified)

Principal functions of MA Division

Medical Plan(Development of Medical Plan, in-licensing,

communication with PMDA, etc.)

MSL(KTL/KOL engagement, etc.)

Medical information(Call Center, literature search, training, etc.)

Clinical study(Planning/operation of company sponsored studies,

HEOR, publication of papers, support for

investigator sponsored studies, etc.)

Compliance management(GxP, risk management, compliance with

transparency guidelines, etc.)

MSL

KOL/KTL

Source: MSL Recommendations Interim Report , 2016 JAPhMed Annual Meeting

Com-

pound

Enrichment of Information Enhances Value of Drug

• Kotler, Philip. 1986. Marketing Essentials. Tokai University Press.

• Maeda, Eiji. 2010. Iryou-you Iyakuhin Marketing (Marketing of Ethical Drugs).

Medical Review (partially modified)

High-quality science-based data, information

useful for patients, healthcare professionals,

medical institutions/healthcare payers, etc.

Information on efficacy and

safety available at time of

approval

Com-

pound

Post-marketing

addition of value-

added information

Enhancement of value of drug via

enrichment of information

• The value of drug is enhanced only when associated information is added to the value of the compound.

• The value of drug is enhanced by enriching associated information.

Value of drug

Product name

(brand)

Package

insert

Price

(value)

Dosage

form

Packaging


Positioning of MSL in Pharmaceutical Companies

Medical Affairs

(MA)

Sales &

Marketing

(S&M)

Medical Director

(MD)

Medical Science Liaison

(MSL)

Publication Manager

(Pub.M)

Research Manager

(Res.M)

Medical Information

(MI)

Medical Writer

(MW)

Project Manager

(PM)Un

bu

nd

lin

g


What is Medical Science Liaison*?

A person with a role independent of the divisions in charge of sales

and marketing of products, who has an advanced level of

medical/scientific expertise and knowledge** and internally/externally

leads to promote proper use of products, optimization of product

value, etc. from a medical/scientific perspective.

Specifically, the person contributes to solving unmet medical needs

through medical/scientific exchanges, conference activities, etc. with

outside medical experts and researchers.

*Also known as “Medical Scientific Liaison”

**Medical/pharmaceutical academic background, preferably having

healthcare qualifications (medical license, pharmacist license, etc.) and

academic degrees (master, PhD, etc.)

Source: MSL Recommendations Interim Report, 2016 JAPhMed Annual Meeting (partially modified)

Note: Items written in blue are at the discretion of individual companies.

GVP: Good Vigilance Practice

GPP: God Publication Practice Guideline

Main Duties of MSL (Details): To identify unmet medical needs (UMNs)

through medical/scientific exchanges with KTL/KOL and to contribute

to solving the UMNs on the basis of Medical Plan

Provision/collection/sharing of information

•Selection of KTLs/KOLs (Establishment/maintenance of relationship)

•Provision of latest information on product/ therapeutic area (within the scope of approval), medical/scientific exchange

•Feedback on medical/scientific exchange to relevant departments:Identification of UMNs/conversion of information into insight

•Support for long-term direction of therapies for the assigned therapeutic area/ promotion of therapeutic awareness

•Planning/holding of Medical Advisory Board Meetings (MABMs)

•Collection of latest information at conferences/feedback to relevant departments

Strategy/plan

• Support for the development

of Medical Plan

• Support for LCM Plan

(overall)

• Support for planning/

management of clinical

studies (individual CIS)

• Communication with relevant global departments

Results/communication

• Submission of papers and

conference presentations

with compliance and GPP3

taken into account

• Support for creation of slides

• Support for holding of events

(e.g. joint seminar) at a

conference organized by MA

Collaboration with GVP division

Contribution to

healthcare

Optimization of

product value


Activities of MSL upon Request by

Internal/External Stakeholders

Note: Items written in blue are at the discretion of individual companies.

15

Support for clinical trials

Company contact point for investigator Initiated studies (IISs)

Communication with healthcare professionals concerning IISs

Support for post-marketing clinical trials

Provision of information on unapproved drugs and off-label use of approved drugs

for non-promotional purposes upon request

Explanation about scientific information that MRs cannot deal with

Support for education of MRs

Review of speakers’ slides to be presented at a company-sponsored/co-sponsored seminar

Communication of outcome of MSL activities to relevant departments/top management

Laws and Regulations/Industry Rules on MSL Activities 1

Activity Rules and regulations/industry rules, references.

Separation/

independence from

Sales and Marketing

Division

Industry rules • Guidelines on Support for Investigator Initiated Study Using Ethical Drugs (Japan

Pharmaceutical Manufacturers Association [JPMA]; January 21, 2016)

Other • Report on the State of the Systems Associated with Clinical Research (Study Committee

for the State of the Systems associated with Clinical Research; December 11, 2014)

• Response and Preventive Measures Based on Clinical Research of Antihypertensives

(Report) (Study Committee on Clinical Trials of Antihypertensives; April 11, 2014)

• US: Federal Register / Vol. 68, No. 86 / Monday, May 5, 2003

• “OIG Compliance Program Guidance for Pharmaceutical Manufacturers “➡ Historical background of the MSL roles

Provision of

information on pre-

marketed drugs/off-

label use for non-

promotional

purposes

Pharmaceuticals and

Medical Devices Law

• Article 66 (Prohibition of False or Exaggerated Advertising)

• Article 68 (Prohibition of Advertising Prior to Approval)

• Article 68-2 (Provision of Information, etc.)

• Guidelines for providing activities of sales information (partly April 1, 2019, full October 1,

2019

Industry rules • JPMA Promotion Code

• Review of “Development of Guidelines for Medical Information Associated with Off-label

Use of Drugs (Request)” (PFSB/Compliance and Narcotics Division Notification No. 1008-4

and Notification issued by the Director of Compliance and Narcotics Division dated October

8, 2010) by the Federation of Pharmaceutical Manufacturers’ Associations of JAPAN

(FPMAJ) and Final Report (FPMAJ Notification No. 590; September 14, 2011)

• IFAPP International Code of Ethical Conduct for Pharmaceutical Physicians (2003)

16

Laws and Regulations/Industry Rules on MSL Activities 2

17

Activity Rules and regulations/industry rules, references.

Support for Investigator Sponsored Study

Laws/guidelines, etc. • (New) Clinical Trials Act (disclosure of funding) full implement April 1, 2019• Ethical Guidelines for Biomedical Research Involving Human Subjects, GCP Ordinance.

Industry rules • Guidelines for Support for Investigator Initiated Study Using Ethical Drugs (Japan Pharmaceutical Manufacturers Association [JPMA]; January 21, 2016)

• IFAPP (2003)• Best of Practice (ACRP/IISRA; 2010)• IISRA FMV Guidance Document (ACRP; 2013)• Transparency GL, Sunshine Act, EFPIA HCP/HCO Disclosure Code

Other • Recommendation paper issued by PhRMA/EFPIA/JPMA• COI guidelines• Recommendation: Promotion/Enhancement of Confirmatory Study Toward Evidence

Generation (Science Council of Japan; July 2011)

Clinical study (collection of safety information)

Pharmaceuticals and Medical Devices Law

European GVP

• Collection of safety information (Pharmaceuticals and Medical Devices Law, Article 68-10, Item 1)

• Collection of safety information from ISS/ISR (Pharmaceuticals and Medical Devices Law, Article 68-10, Item 2)

Holding of MAB meeting/lecture meeting, review of slides

Industry rules • Code of Fair Competition• Transparency GL, Sunshine Act, EFPIA HCP/HCO Disclosure Code

Other • Recommendation on Holding of Medical Advisory Board Meeting (JAPhMed; November 10, 2015)

MSL activities

Law • Act on the Protection of Personal Information

Industry recommendations

• The positioning and activity principles of MSL (EFPIA; 2015, PhRMA; 2019, JPMA; 2019)

Provision of information on pre-marketed drugs/off-

label use for non-promotional purposes

Article 66 (Prohibition of False or Exaggerated Advertising)

Articles that are explicitly or implicitly false or exaggerated shall not be advertised, described

or disseminated.

Article 68 (Prohibition of Advertising Prior to Approval)

For unapproved drugs… indication or performance shall not be advertised.

Article 68-2 (Provision of Information, etc.)

…shall endeavor to collect and examine information necessary to ensure proper use of

drugs and to provide such information to proprietors of pharmacy, hospitals… healthcare

professionals.

18

Points in Providing Information on Off-label Use of Drugs

The Federation of Pharmaceutical Manufacturers’

Associations of JAPAN (FPMAJ) 1

19

• Review of “Development of Guidelines for Medical Information Associated with Off-label Use of Drugs (Request)” (PFSB/Compliance and Narcotics

Division Notification No. 1008-4 and Notification issued by the Director of Compliance and Narcotics Division dated October 8, 2010) by the Federation of Pharmaceutical Manufacturers’ Associations of JAPAN (FPMAJ) and Final Report (FPMAJ Notification No. 590; September 14, 2011)

Provide information only when requested by healthcare professionals.

(Prohibition of provision of information for promotional purposes)

Provide only published papers supported by evidence whose quality has been

objectively and scientifically evaluated.

For evaluation of the evidence level of materials, define internal criteria or

procedures to ensure proper management of the subject papers.

When providing information, present individual adverse drug reaction reports

and accumulated information as well as their whole picture of the safety

information of the relevant drug.

Pay attention when handling information on a drug for which application based

on data from the public domain was made and insurance reimbursement

notified and when putting out a news release as part of IR activities.

Points in Providing Information on Off-label Use of Drugs

FPMAJ 2

20

Key Performance Indicators (KPIs) of MSL

Select appropriate KTL/KOL

Summarize and report the result of the interaction with KTL/KOL scientifically

Maintain relationship of trust with KTL/KOL based on advanced medical knowledge

Identified valuable UMNs and Medical Insights

• Evaluate the impact of obtained UMNs and Medical Insights.

• Organize and execute meaningful events that lead to UMNs and/or Medical Insights (e.g. Advisory Board meetings, Scientific Exchange meetings)..

• Attainment level of medical Advisory Board meeting goals against plan..

• Whether the meetings were conducted as planned (from planning to holding).

Support for company initiated studies

• Contribution to achievement rateActivities under compliance


MSL Requirements: Qualification

Qualification Requirements

– Medical/pharmaceutical academic background

• Having academic degree (master, PhD) or preferably

healthcare qualifications (physician, dentist, pharmacist,

nurse, veterinary)

– Receiving continuous education/training on related

regulations and internal standard operating procedures

(SOPs)


MSL Requirements: Ability

Recommended ability requirements– Have an advanced level of medical/ scientific knowledge in the

assigned therapeutic area.

– Ensure scientific rationality and ethical validity, and can makea correct, fair and objective judgment based on a reasonablebasis.

– Communicate factual, accurate, fair and meaningful scientificinformation to healthcare professionals.

Basic requirements

• Understand the roles and missions of MSL

• Have high ethical standards

• Protect confidentiality

• Have general knowledge about clinical researches

• Understand and comply with relevant regulatory requirementsand company SOPs


FAQ About Qualification Requirements

Medical/pharmaceutical academic background

– Those educated in the faculty/department of medicine, dentistry, pharmacy,

nursing and other life science related faculties/departments. For other life

science related faculties/departments, relevance with characteristics and target

therapeutic of individual companies’ drugs/medical devices is taken into account.

Although those with other scientific background and without scientific background can be

accepted in accordance with the JAPhMed accreditation:

– These JAPhMed recommendations primarily look 5 or 10 years ahead and

JAPhMed will not accept the situation as is.

– However, for those who have been acting as MSL, JAPhMed does not prohibit

their activities provided that they meet internal certification requirements with

working years and external training received taken into account. The history of

academic activities (conference presentation, paper writing) and professional

qualifications, experience and knowledge in biostatistics, health economic

evaluation, etc. are also considered.


MSL Training Outline

Disease-based training

Medical Strategies

MSL SOPs

Induction Training Maintenance

Advanced

Product Strategies

Product-based training

Information update

Conferences, papers,

etc.

Research trend

Basic

Laws and regulations

Business skills

Management skills

Leadership skills

Basic medical

knowledge

Update of basics

Industry trend

Clinical Study


MSL Training Curricula Development Process

Identification and tabulation of major/intermediate categories of curricula based on the MSL accreditation standards

Consideration of necessity of additional curricula for MSL activities after interim announcement

Refinement of the major/intermediate categories and evaluation of their appropriateness

Presentation of the relationship between individual MSL activities and curricula in a diagram and examination of the relationship

Definition of Overview/Reason to

learn/What to learn for the

major/intermediate categories

considered

Major Contents of Training Curriculum

1.MSL Introductory Education: Medical Affairs (MA)

2.MSL Introductory Education: Basic Knowledge About MA

3.Related Laws and Regulations/Regulation/Rules

4.Research Ethics

5.Overview of Drug Development

6.Basics of Clinical Research (Intervention Study, Observational

Study, Database Study)

7.Publication

8.Therapeutic Area/Product Knowledge

9.Business Skills of MSL

Feedback on

medical/scientific

exchanges to relevant

departments

Collection of

UMNs/insights

Knowledge on products in the

assigned therapeutic area

Acquisition of knowledge on the

assigned therapeutic area as a

basic mandatory requirement

Business skill: Soft Skill

• Communication skill to collect

information

Necessary to communicate with

internal/external stakeholders as MSL

Basic knowledge about MA

• Medical Plan＆LCM

• MSL SOP (JP/US/EU)

• Definition of insight/UMN

Clarify objectives of MA

Division.

Understand what to do to

achieve the objectives.

What is MA?

• Necessity and functions/roles of

MA organization

Relevant laws/regulations/rules

• Pharmaceuticals and Medical

Devices Law

• JPMA COP

• Transparency Guidelines

• Code of Fair Competition

Understand dos/don’ts for MSL which should

be reflected in SOPs/KPIs.

Clinical research

• Basics of Clinical Research• Basics of protocol development• Basics of performance of

clinical research

Research ethics

• Integrated Guidelines

• Clinical Research Law

• IIS Support Guidelines

Publication

• ICMJE/GPP3

Overview of drug development

• Flow of drug development

• Basics of ICH-GCP/J-GCP

• Basics of GVP/RPM/GPSP

It is important to understand basics of clinical study in order

to integrate obtained information to identify UMNs and

insights and to provide feedback that possibly leads to

discovery of new medical value.

Before understanding activities of MA

MSL Certification process

Conduct training curriculum

(3 – 4 months)

On the job training

Select from KPIs

e.g. Conduct unbiased and

objective communication

based on the latest

scientific information.

Quality of KOL engagement.

( approximately 6 months)

Assessment

confirmation tests/field test

Certificate

Disqualification

Regular continuing training

Follow up training

(6-12 months)

Re-certificate

(every 1-2 years)

1. MSL Introductory Education: Medical Affairs

(MA)

MSL Training Content and Overview

1. MSL Introductory Education: Medical Affairs (MA)

1-1Historical Background of MA

(Changes in the Environment Surrounding Healthcare and Industry Trend)

1-2 Functions and Roles of MA, Relationship with Sales and Marketing

1-3 Roles of MSL in MA

Overview

After entering the 21st century, Medical Affairs (MA), a division independent of Sales and Marketing

Division which has already been established by European and US companies, has been set up by

Japanese pharmaceutical companies . Accordingly, a role of Medical Science Liaison (MSL) in

charge of evidence generation and provision of advanced medical/scientific information has been

created, which has shown rapid growth, first in foreign affiliated companies and gradually in

domestic companies. Understanding the background of establishment of this type of division/role

will help clear identification of job objectives of MSL. It is specifically important to understand what

independence from Sales and Marketing Division actually means and respective roles in order to

avoid misunderstanding by other divisions and to establish mutually respectful relationship, thereby

appropriately performing respective duties.

Training Content: Essential Learning Items


1-1

Historical Background of MA

(Changes in the Environment Surrounding Healthcare and

Industry Trend)

Reason to

learn

• A new division/role attracts attention for a while after its creation. Without clear

objectives and outcome, however, acceptance of the division/role by and

motivation to work with the division/role of other divisions would not be

promoted. By learning the historical background of MA (i.e. reason of

establishment) and its duties, MSL can better identify his/her roles and duties

and respond to questions from other divisions, thereby promoting their

understanding.

What to learn• Roles and objectives of MA and the event that led to the creation of MA

• Problems with the event and how MA should address such problems



1-2 Functions and Roles of MA, Relationship with Sales and Marketing

Reason to

learn

• It is important to clearly understand the division of duties between MA Division

and Sales and Marketing Division which is in charge of sales promotion.

Understanding of the functions/roles of MA Division and difference from those of

Sales and Marketing Division facilitates performance of assigned duties.

What to learn

• Internal positioning of MA (i.e. roles of MA and relationship with other

departments) in the organization chart

• Duties of MA

• Duties/strategies of each department of MA

• Ability to answer to questions from KTLs/KOLs regarding roles of MA and Sales

and Marketing Divisions in a concise and easy-to-understand manner

• MSL is not allowed to actively provide information on unapproved drugs/off-label

use. MSL may provide such information in accordance with the internal rules

only when requested by healthcare professionals via KTLs/KOLs or Sales and

Marketing Division.



1-3 Roles of MSL in MA

Reason to

learn

• By understanding the roles of MSL in MA as well as dos and don’ts for MSL to

properly play its roles, high quality and integrity of MSL functions in MA can be

promoted and maintained.

What to learn

• Roles to be played by MSL in MA

• Difference between goals of MSL and MR

• Procedures for meeting with KTLs/KOLs (preparation meeting reporting)

How to learn

• Since the roles of MSL varies among companies, it is helpful for each company

to prepare and use training materials that clearly define the roles of and dos and

don’ts for MSL and MR.

• Prepare MSL SOP that clearly describes the roles of and dos and don’ts for

MSL to promote understanding by other divisions via group training or e-

learning.



How to learnGroup training targeting newly appointed and transferred MSLs by using slides

prepared by each company for introductory education

References

• Morgan et al. Drug Information Journal 2000

History and Evolution of Field Based Medical Program

• Clinical Research Professionals No. 22 2011

Medical Affairs-ni okeru Ishi-no Yakuwari-ni tsuite

(Roles of Physicians in Medical Affairs)• Chin, Jane, PhD;Massey, Kenneth L, PharmD;Black,

Jimmy, PharmD. Drug Information Journal; Nov 2011;

45, 6; ProQuestpg. 819

Certification for the Medical Science Liaison: An Idea

Whose Time Has Come-or Not



References

• Inoue, Youichi. International Pharmaceutical Information Sept 2012;

Nihon-ni okeru Medical Affairs bumon-no Tenkai

(Development of Medical Affairs in Japan)

• Fridsma D.B. J Am Med Inform Assoc 2015;

22:489–490：Update on informatics-focused

certification and accreditation activities.• Medical Science Liaison Society Website

http://www.themsls.org/

• The MSL Journal

http://themsljournal.com/

http://www.themsls.org/

http://themsljournal.com/

2. MSL INTRODUCTORY EDUCATION:

BASIC KNOWLEDGE ABOUT MA

37


38

2. MSL Introductory Education: Basic Knowledge About MA

2-1 Mission, Vision, Value

2-2 Medical Plan, Life Cycle Management (LCM)

2-3 KTL (Key Thought Leader)/KOL (Key Opinion Leader) Engagement

2-4 Insights/Unmet Medical Needs (UMNs)

Overview

In this section, it is important to review what was learned in the previous section in light of real

practice. It is also important to understand the missions that MSL has to carry out. The objective of

this section is to learn what roles MSL plays in which stage of product life cycle management

(LCM) as well as what MSL should keep in mind when exchanging/collecting information with/from

KTLs/KOLs in KTL/KOL engagement although main duties of MSL vary among companies

according to therapeutic areas and product stages.


39


2-1 Mission, Vision, Value

Reason to

learn

• Understanding of missions of MA, what it means to achieve mid- and long-term

objectives based on the missions, and what kind of organization MA should be

for the company and healthcare promotes MSL’s awareness about his/her roles.

What to learn

• Duties of MA and MSL including:

- Missions, objectives, roles

- Mid- and long-term goals, direction (what the division and therapeutic area

pursue)

- Benefits to be brought to healthcare professionals and patients


40


2-2 Medical Plan, Life Cycle Management (LCM)

Reason to

learn

• One of the main duties of MA is LCM which is basically comprised of cross-

functional activities. Understanding what LCM is, how LCM flows, and what

roles MA/MSL play in LCM facilitates clear identification of LCM-related

activities to be carried out by MA/MSL.

What to learn

• What is LCM and the duties to be carried out in each stage of LCM from

development through patent expiration (often beyond patent expiration)

• What activities should be carried out in the LCM stages for which MA is

responsible, objectives of the activities, and final deliverables

• Clear division of MSL and non-MSL duties within MA for clear definition of MSL

activities

How to learn • Group training during MSL introductory training is recommended.


41


2-3 KTL/KOL Engagement

Reason to

learn

• Exchanges with experts in the assigned area (i.e. KTLs/KOLs) is one of the

main activities of MSL. Understanding what experts are selected by R&D, Sales

and Marketing, and MA Divisions, and the difference in what is exchanged with

these experts between these divisions facilitates performance of duties by MSL.

What to learn

• KTL/KOL

• KTL/KOL engagement

• Difference from Sales and Marketing Division in terms of selection of

KTLs/KOLs and what is exchanged with KTLs/KOLs

How to learn • Group training during MSL introductory training is recommended.


42


2-4 Insights/UMNs

Reason to

learn

• Strategic objectives of MSL include to collaborate with internal and outside

stakeholders through exchange of clinical/scientific data, to identify unmet

medical needs, and to clarify appropriate standard of care in the assigned

therapeutic area. MSL should always pay attention to insights and UMNs in

order to identify unsolved issues, which are directly associated with research

performed by MA, through exchanges with KTLs/KOLs.

What to learn

• Insight (general/medical)

• UMNs

• Incorporation of insight and UMNs into exchange with KTLs/KOLs

How to learn

• Group training during MSL introductory training is recommended.

After acquiring general knowledge, discuss unsolved issues with the assigned

therapeutic area/product and possible insights in a workshop format.

3. RELATED LAWS AND

REGULATIONS/REGULATION/RULES

43


44

3. Related Laws and Regulations/Regulation/Rules

3-1 Pharmaceuticals and Medical Devices Law

3-2 Code of Practice (IFPMA/JPMA), Code of Fair Competition, etc.

3-3 MSL Guidelines (PhRMA/EFPIA)

3-4 Transparency Guidelines

3-5 Corporate Code of Conduct/Compliance

3-6 MSL SOP (JP/US/EU)

3-7 MA Division Rules

3-8 National Public Service Ethics Law, Anti-corruption Act/Bribery Act

Overview

To ensure proper provision of information on unapproved drugs/off-label use, it is necessary to

understand relevant rules and regulations. For MSL activities, it is also necessary to understand

difference from information provision for promotional purposes, how MSL should be, and various

rules including internal MA rules.


45


3-1 Pharmaceuticals and Medical Devices Law

Reason to

learn

• In order to ensure proper provision of information on unapproved drugs/off-label use upon request by healthcare professionals, it is necessary to understand relevant laws and regulations as well as industry rules.

What to learn

• Provision of high-quality information to healthcare professionals is required. Upon request of the Ministry of Health, Labor and Welfare (MHLW), FPMAJ has established the rules for provision of information of unapproved drugs, etc. based on those established overseas. Understand the background and contents of the rules and consider the significance of provision of information on unapproved drugs/off-label use by MSL.

How to learn• Understand contents of provisions on advertising of the Pharmaceuticals and

Medical Devices Law and references.

References

• Article 68, etc., Pharmaceuticals and Medical Devices Law• Review of “Development of Guidelines for Medical Information Associated with Off-

label Use of Drugs (Request)” by the Federation of Pharmaceutical Manufacturers’ Associations of JAPAN (FPMAJ) and Final Report (FPMAJ Notification No. 590; September 14, 2011)


46


3-2 Code of Practice (IFPMA/JPMA), Code of Fair Competition, etc.

Reason to

learn

• The “IFPMA Code of Practice” on which JPMA Code of Practice is based is the

international voluntary standards for the pharmaceutical industry established by

the International Federation of Pharmaceutical Manufacturers & Associations

(IFPMA) that define ethical promotion of drugs to healthcare professionals and

exchange between member companies and healthcare professionals. The

IFPMA Code of Practice is applicable to wide range of corporate activities

including marketing.

As with the IFPMA Code of Practice, the Code of Fair Competition, which is an

industry code based on the Act against Unjustifiable Premiums and Misleading

Representations, must be followed.

What to learn• Understand promotional and non-promotional activities, which means the

understanding promotional activities is assist well awareness of non-promotional activities and those difference, and highly ethical activities

How to learn • Understand the contents of the reference.

Referencehttp://www.jpma.or.jp/about/basis/code/ifpmacode.html

(JPMA Code of Practice, IFPMA Code 2012)

http://www.jpma.or.jp/about/basis/code/ifpmacode.html


47


3-3 MSL Guidelines (PhRMA/EFPIA)

Reason to

learn

• Since MSL activities are recognized by healthcare professionals, etc. in Europe

and the US, MSL Guidelines of PhRMA and EFPIA can serve as a reference.

What to learn

• Requirements of MSL defined by PhRMA/EFPIA (qualifications, activities,

attitude, etc.) and difference from those pursued by JAPhMed

• Refer to the JPMA Guidelines when released.

How to learn • Understand the contents of the references.

References

• The positioning and activity principles of MSL (EFPIA-J Corporate Ethics

Committee; October 2017)

• Position Statement: PhRMA Principles to Govern Pharmaceutical Company

Support of Investigator Initiated Studies (March 11, 2014)


48


3-4 Transparency Guidelines

Reason to

learn

• In the course of activities carried out by MSL, payment to KTLs/KOLs, etc. associated with the Medical Advisory Board Meetings, conduct of studies, lectures, etc. occurs. Transparency of such payment must be ensured for the pharmaceutical industry to contribute to the advancement of life science including medical and pharmaceutical sciences.

What to learn• Background of ensuring transparency of relationship between companies and

healthcare professionals and how to disclose information as well as difference between JPMA guidelines and overseas regulations

How to learn • Understand the contents of the references.

References

• Transparency Guideline for the Relation between Corporate Activities and Medical Institutions (Japan Pharmaceutical Manufacturers Association [JPMA];revised on March 21, 2013)

• EFPIA: EFPIA HCP/HCO Disclosure Codehttps://www.efpia.eu/media/25837/efpia-disclosure-code.pdf

• PhRMA:http://www.phrma.org/press-release/statement-on-physician-

payments-sunshine-act

https://www.efpia.eu/media/25837/efpia-disclosure-code.pdf

http://www.phrma.org/press-release/statement-on-physician-payments-sunshine-act


49


3-5 Corporate Code of Conduct/Compliance

Reason to

learn

• The provisions of various laws and regulation, industry rules, etc. that stipulate

MSL activities are incorporated into internal rules. In order to maintain fair and

ethical conduct of MSL activities, it is necessary to ensure company-wide

awareness of the standardized rules. It is also important to understand the limit

on the activities in order to achieve the greatest impact within the framework of

the rules.

What to learn • What MSL can and cannot do

References • Internal materials


50


3-6 MSL SOP (JP/US/EU）

Reason to

learn

• For activities that do not deviate from the corporate code of conduct/compliance,

it is recommended to prepare SOPs that define specific works.

In order to maximize the impact of MSL activities, it is necessary to collaborate

with MA/MSL in Europe and the US, which require global SOPs as appropriate.

What to learn

• Standard procedures with their background covered by separate education

curricula

• Background of internationally coordinated SOPs

References • Internal materials and materials of overseas group companies


51


3-7 MA Division Rules

Reason to

learn

• MSL carries out activities including exchange of opinions with KTLs/KOLs

towards realizing the vision/missions of MA. Hence it is important for MSL to

understand not only rules of MSL activities (e.g. exchanges with KTLs/KOLs,

provision of information on off-label use, Medical Advisory Board Meetings,

holding of lecture meetings) but also basic MA Division Rules.

What to learn • MA Division Rules and their background

References • Internal materials


52


3-8 National Public Service Ethics Law, Anti-corruption Act/Bribery Act

Reason to

learn

• Public service officials and other person equivalent thereto are required to fairly perform their duties. The activities which may bring about suspicion and distrust from the citizens including receiving gifts from those who have interests with the duties of the officials are prohibited or limited regardless of whether or not performance of their duties are directly impacted. Since noncompliance with these laws and regulations in the course of carrying out activities of MSL may cause trouble to KTLs/KOLs, MSL is required to be well versed in the relevant laws and regulations

What to learn• Restrictions stipulated by the National Public Service Ethics Law (Japan) and anti-

corruption act/bribery act (overseas)

How to learn • See the references (websites).

References

• National Public Service Ethics Board: http://www.jinji.go.jp/rinri/index.htm

• Foreign Corrupt Practices Act (FCPA): https://www.justice.gov/sites/default/files/criminal-fraud/legacy/2015/01/16/guide.pdf

• Bribery Act:https://www.legislation.gov.uk/ukpga/2010/23/contents

http://www.jinji.go.jp/rinri/index.htm

https://www.justice.gov/sites/default/files/criminal-fraud/legacy/2015/01/16/guide.pdf

https://www.legislation.gov.uk/ukpga/2010/23/contents

53

4. RESEARCH ETHICS

Research Ethics and Overview

54

4. Research Ethics

4-1 Historical Background of Research Ethics

4-2Ethical Guidelines for Medical and Health Research Involving Human

Subjects (Including Difference Between ICH-GCP and J-GCP)

4-3Clinical Research Law (Historical Background and Difference in Laws and

Regulations Between Japan and Europe/US)

4-4 IIS Support Guidelines (JPMA, PhRMA, EFPIA)

4-5 Compensation and Reparations

4-6 Act on the Protection of Personal Information

Overview

To act as contact point for IIS support and to support planning/operation of company initiated

studies (CIS), etc., it is important to understand that clinical research must be ethical.

Understanding of the framework for IIS support/performance of CIS, implementation standards,

compensation, etc. is also important.


55

4. Research Ethics


Reason to

learn

• In light of human experimentations performed by Nazi Germany during World

War II and inhuman research conducted after the war, ethical guidelines

including the Nuremberg Code, the Declaration of Helsinki, and the Belmont

Report were developed with the guidelines for clinical research stipulated and

updated by the World Health Organization (WHO), the World Medical

Association (WMA), the Council for International Organizations of Medical

Sciences (CIOMS), etc. Discussions about IIS/CIS should be based on

thorough understanding of the historical background of and latest guidelines for

research ethics.

What to learn

• Historical background of representative events concerning research ethics

including the Nuremberg Code, the Belmont Report, and the Declaration of

Helsinki; research ethics stipulated by the WMA and CIOMS ethical guidelines

• Transition of the Pharmaceutical Affairs Law, etc. in Japan in the wake of drug

induced diseases (e.g. thalidomide) and deaths (sorivudine), etc. (basic

knowledge for discussion about research)


56

4. Research Ethics


How to learn/

Available tools

• Educational materials appropriate for the organization/condition of individual

companies, lecture meetings

• Self-learning by e-learning

References

• World Medical Association (WMA)

• International Ethical Guidelines for Biomedical Research Involving Human

Subject issued by the Council for International Organizations of Medical

Sciences (CIOMS)


57

4. Research Ethics

4-2Integrated Guidelines

(Including Difference Between ICH-GCP and J-GCP)

Reason to

learn

• The ethical guidelines as implementation standards for clinical research were

established separately from GCP for clinical trials and evolved into the ethical

guidelines for medical and health research involving human subjects, which is

considered rare in the world. It is recommended to understand the difference

from GCP as well as international ethical guidelines of CIOMS, etc. when

submitting papers to overseas journals.

What to learn

• Contents of Ethical Guidelines for Medical and Health Research Involving Human

Subjects

• Difference from ICH-GCP, J-GCP, CIOMS ethical guidelines, etc.

How to learn/

Available tools




References

• WHO-GCP, ICH-GCP, GCP Ordinance

• International Ethical Guidelines for Biomedical Research Involving Human

Subject (CIOMS; 2016)


58

4. Research Ethics

4-3Clinical Research Law (Historical Background and Difference in

Laws and Regulations Between Japan and Europe/US)

Reason to

learn

• Since conventional idea that the human nature is fundamentally good is no

longer applicable to clinical research, the research is bound by the Clinical

Research Law. It is recommended to understand the background of

introduction of the law as well as the framework for clinical research in Europe

and the US.

What to learn

• Background and contents of the Clinical Research Law in Japan, framework for

clinical research in Europe and the US, domestic/overseas implementation

standards, etc.

How to learn/

Available tools




References

• Report on Systems Associated with Clinical Research (December 11, 2014)

• Clinical Research Law (draft)

• European Medicines Agency (EMA): EU Regulation

• Food and Drug Administration (FDA): CRF Common Rules, IND system, etc.


59

4. Research Ethics


Reason to

learn

• Understanding of how IIS support should be forms the basis for discussion with

KTLs/KOLs about IIS, acting as company contact point, etc.

• While funding by companies is important for supporting research by academia

and industry-academia collaboration, it is also important to understand possible

conflict of interest (COI) and its management.

What to learn

• Fact that COI is not always evil, importance and method of COI management

(with reference to the background of the Clinical Research Law and

ICMJE/GPP3)

• The direction JPMA is heading for while referring to IIS support by foreign-

affiliated companies of the Pharmaceutical Research and Manufacturers of

America (PhRMA), European Federation of Pharmaceutical Industries and

Associations (EFPIA), etc.

• Contents of the IIS Support Guidelines of JPMA


60

4. Research Ethics


How to learn/

Available tools




References

• JPMA: Basic Principles of Support for Company Sponsored Study (2014);

Notes on Company-funded Investigator Initiated Study (2015)

• PhRMA: Position Statement: PhRMA Principles to Govern Pharmaceutical

Company Support of Investigator Initiated Studies (2014)

• EFPIA: Guidelines for Funding for Investigator Initiated Study (IIS) via

Conclusion of a Contract (2014)

• ACRP: Best Practice of Guideline(2011)

• Japan Pharmaceutical Industry Legal Affairs Association/JAPhMed:

Investigator Sponsored Study Contract (ver. 3.1)

• COI management: CIOMS Ethical Guidelines (2016)


61

4. Research Ethics

4-5 Compensation and Reparations

Reason to

learn

• As with clinical trials, compensations and reparations are important factors of

clinical research from the perspective of protecting research subjects. The

difference between compensation and reparations must be clearly understood.

What to learn

• Compensation required by the Declaration of Helsinki, GCP Ordinance, Ethical

Guidelines for Medical and Health Research Involving Human Subjects, etc. and

their concept of compensation

• Framework for compensation in clinical research, post-marketing clinical

study/survey

How to learn/

Available tools




References

• Ethical Guidelines for Medical and Health Research Involving Human Subjects

(revised in 2017)

• Japan Pharmaceutical Industry Legal Affairs Association:

Guidelines Concerning Health Damage Compensation for Subjects (2015)

• Declaration of Helsinki, CIOMS Ethical Guidelines 2016, Guidance on GCP

Ordinance, Clinical Research Law


62

4. Research Ethics

4-6 Act on the Protection of Personal Information

Reason to

learn

• It is recommended to understand about the Amended Act on the Protection of

Personal Information together with the revised ethical guidelines. Specifically,

attention should be paid to handling of data, personal names, etc. that are

outside the scope of the ethical guidelines.

What to learn

• New definition of personal information, direction of promoting utilization of

personal data (big data, etc.) pursued by the Amended Act on the Protection of

Personal Information

• (For medical data) Anonymized information, new Act on Medical Big Data

(tentative name)

How to learn/

Available tools




References

• Personal Information Protection Commission Japan:

http://www.ppc.go.jp/

• Act on Medical Big Data: Cabinet Secretariat website; 193rd Ordinary Diet

Session

http://www.ppc.go.jp/

5. OVERVIEW OF DRUG DEVELOPMENT

63


64

5. Overview of Drug Development

5-1 Flow of Drug Development

5-2 Basics of Non-clinical Studies

5-3 Basics of ICH-GCP/J-GCP

5-4 Basics of GPSP

5-5 GVP/RMP

5-6 Basics of Intellectual Properties

Overview

To discuss clinical questions (CQs), etc. with KTLs/KOLs, to act as contact person for IIIS support,

and to support planning/operation of CIS, etc., it is important to understand the flow of drug

development from non-clinical studies to clinical development and post-marketing activities.


65



Reason to

learn

• It is important and helpful to understand how the company’s own products were

developed as well as the flow of drug development in order to discuss clinical

questions (CQs), etc. with KTLs/KOLs.

What to learn

• Flow of drug development from non-clinical to clinical studies and obtaining of

approval; limitations of clinical studies for approval

• Post-marketing clinical studies/surveys and involvement of MA Division in

these studies/surveys


66



How to learn/

Available tools




References

• JPMA textbooks, OPIR News Views and Actions, Research Papers, etc.

http://www.jpma.or.jp/about/issue/gratis/• Drug Approval and Licensing Procedures in Japan (Jiho Inc.)

• PMDA: ICH Guideline website

https://www.pmda.go.jp/int-activities/int-harmony/ich/0070.html

http://www.jpma.or.jp/about/issue/gratis/



67


5-2 Basics of Non-clinical Studies

Reason to

learn

• It is important and helpful to understand the non-clinical characteristics of the

company’s own products as well as basics of non-clinical studies in order to

discuss clinical questions (CQs), etc. with KTLs/KOLs.

What to learn

• Types of non-clinical studies in drug development (safety [toxicity] study,

pharmacology study, pharmacokinetic study, formulation study, etc.)

• Correct understanding of non-clinical study data

How to learn/

Available tools




References

• PMDA: ICH guideline website




68


5-3 Basics of ICH-GCP/J-GCP

Reason to

learn

• To act as contact person for IIS support and to support planning/operation of

CIS, etc., it is essential to acquire basic knowledge of ICH-GCP and J-GCP.

What to learn

• What is written in ICH-GCP and J-GCP (It is not essential to remember the

contents.)

• Difference between ICH-GCP and J-GCP

How to learn/

Available tools

• Self-learning through reference materials


References

• ICH-GCP; Ministerial Ordinance on Good Clinical Practice for Drugs,

Enforcement of the Ordinance Regarding Good Clinical Practice (PAB

Notification No. 430 dated March 27, 1997)


• Contents of GCP (Central Pharmaceutical Affairs Council Report dated March

13, 1997), Partial Amendment of the Guidance on Ministerial Ordinance on

Good Clinical Practice (PFSB/ELD Notification No. 0404-4 dated April 4, 2013)



69


5-4 Basics of GPSP

Reason to

learn

• To act as contact person for IIS support, to support planning/operation of CIS,etc. and to discuss CQs, etc. with KTLs/KOLs, it is helpful to acquire basicknowledge of the Good Post-marketing Study Practice (GPSP).

What to learn• What is written in the GPSP Ordinance (It is not essential to remember the

contents.)

How to learn/

Available tools

• Educational materials appropriate for the organization/condition of individualcompanies, lecture meetings


References

• Ministerial Ordinance on Good Post-marketing Study Practice for Drugs;Enforcement of Ministerial Ordinance Regarding Partial Amendment ofMinisterial Ordinance on Standards for Post Marketing Safety Assurance forDrugs, Quasi-drugs, Cosmetics and Medical Devices and Ministerial Ordinanceon Good Post-marketing Study Practice for Drugs (PFSB Notification No. 0311-7 dated March 11, 2013); Enforcement of Ministerial Ordinance on Good Post-marketing Study Practice for Drugs (PFSB Notification No. 1220008 datedDecember 20, 2004)

https://www.pmda.go.jp/review-services/inspections/reexam-reeval/0004.html

https://www.pmda.go.jp/review-services/inspections/reexam-reeval/0004.html


70


5-5 GVP/RMP

Reason to

learn

• Since MSL may be the first detector of adverse event information in the course

of discussion with KTLs/KOLs, it is essential that MSL is well versed in the

Good Pharmacovigilance Practice (GVP).

• To act as contact person for IIS support and to support planning /operation of

CIS, etc., it is helpful to understand GVP /Risk Management Plan (RMP).

What to learn • Basic concept of GVP/RMP

How to learn/

Available tools




References

• JPMA: Pharmaceutical Administration and Regulations in Japan

http://www.jpma.or.jp/about/issue/gratis/index2.html

• PMDA: Drug Risk Management Plan website

https://www.pmda.go.jp/safety/info-services/drugs/items-

information/rmp/0002.html

http://www.jpma.or.jp/about/issue/gratis/index2.html

https://www.pmda.go.jp/safety/info-services/drugs/items-information/rmp/0002.html


71


5-6 Basics of Intellectual Properties

Reason to

learn

• To support development of Medical Plan and LCM Plan, to act as contact

person for IIS support and to support planning/operation of CIS, etc., it is

helpful to acquire basic knowledge of intellectual properties.

What to learn • Basics of intellectual properties

How to learn/

Available tools




References

• JPMA textbooks

http://www.jpma.or.jp/about/issue/gratis/tekisutobook/

http://www.jpma.or.jp/about/issue/gratis/tekisutobook/

6. Clinical Research

72


73


6-1 Basics of Clinical Research (Intervention Study, Observational Study,

Database Study)

6-2 Basics of Protocol Development

6-3 Basics of Clinical Research Operation

6-4 Basics of Statistical Analysis

6-5 Basics of Health Economics

Overview

To act as contact person for IIS support and to support planning/operation of CIS, etc., it is

important to acquire basic knowledge of clinical research in general.


74


6-1Basics of Clinical Research

(Intervention Study, Observational Study, Database Study)

Reason to

learn

• To act as contact person for IIS support and to support planning/ operation of

CIS, etc., it is essential to acquire basic knowledge of clinical research.

• To provide up-to-date information on products/therapeutic areas to KTLs/KOLs

and for medical/scientific exchanges, it is also helpful to acquire basic

knowledge of clinical research.

What to learn

• Characteristics of and difference between intervention study, observational

study, and database study (necessity of consent, burden on subjects, handling

of adverse events, required cost, quality/quantity of data, etc.)

• Advantages and limitations of each type of study

• Representative method of each type of study


75


6-1Basics of Clinical Research

(Intervention Study, Observational Study, Database Study)

How to learn/

Available tools





76


6-2 Basics of Protocol Development

Reason to

learn


CIS, etc., it is helpful to acquire basic knowledge of protocol development.

What to learn• Procedure for developing protocol (from RQ to protocol)

• Basic structure of protocol

How to learn/

Available tools





77


6-3 Basics of Clinical Research Operation

Reason to

learn


CIS, etc., it is helpful to acquire basic knowledge of clinical research operation.

What to learn

• Flow of clinical study

• Roles of Sponsor, Investigator, Institution, EC/IRB, monitor, auditor, etc.

• Importance of IC, QC, adverse event reporting, storage of record, COI, etc.

How to learn/

Available tools





78


6-4 Basics of Statistical Analysis

Reason to

learn


CIS, etc., it is important to acquire basic knowledge of statistical analysis.

• To provide up-to-date information on products/therapeutic areas to KTLs/KOLs

and for medical/scientific exchanges, it is also helpful to acquire basic

knowledge of of statistical analysis.

What to learn• Acquisition of basics of statistical analysis to precisely communicate questions

and information from external researchers to internal statistics experts

How to learn/

Available tools





79


6-5 Basics of Health Economics

Reason to

learn

• To discuss CQs, etc. with KTLs/KOLs, to act as contact person for IIS support,

and to support planning/operation of CIS, etc., it is helpful to acquire basic

knowledge of health economics.

What to learn • Methodology of health economics and its limitations

How to learn/

Available tools



References

• Methods for the Economic Evaluation of Health Care Programmes (Jiho Inc.)

• Guideline for Economic Evaluation of Healthcare Technologies in Japan

http://www.mhlw.go.jp/file/05-Shingikai-12404000-Hokenkyoku-Iryouka/0000109789.pdf

http://www.mhlw.go.jp/file/05-Shingikai-12404000-Hokenkyoku-Iryouka/0000109789.pdf

7.PUBLICATION

80


81

7. Publication

7-1 Guidelines (ICMJE/GPP3)

7-2 Study Registration (UMIN/ClinicalTrials.gov)

7-3 Paper Preparation Guidelines (CONSORT Statement, STROBE Statement)

Overview

To act as contact person for IIS support and to support planning/operation of CIS, etc., it is

important to acquire basic knowledge of publication.


82

7. Publication

7-1 Guidelines (ICMJE/GPP3)

Reason to

learn

• To support paper submission and conference presentation, to act as contact

person for IIS support, and to support planning/operation of CIS, etc., it is

important to understand publication guidelines (ICMJE/GPP3).

What to learn• Basic rules of publication (selection of author[s], conflict of interest/disclosure of

information, copyright, multiple submissions, study registration, etc.)

How to learn/

Available tools

• Self-learning from reference materials.


References

• ICMJE Recommendations

http://www.icmje.org/recommendations/

• GPP3 Guidelines

http://www.ismpp.org/gpp3

http://www.icmje.org/recommendations/

http://www.ismpp.org/gpp3


83

7. Publication

7-2 Study Registration (UMIN/ClinicalTrials.gov)

Reason to

learn



important to understand about study registration.

What to learn

• Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial

Registries and Databases (IFPMA)

• Objectives, scope, registered contents of the UMIN Clinical Trials Registry/

ClinicalTrials.gov

How to learn/

Available tools



References

• Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial

Registries and Databases (IFPMA)

http://www.jpma.or.jp/about/basis/rinsyo/shishin09.html

• UMIN Clinical Trials Registry

http://www.umin.ac.jp/ctr/UMIN-CTR_Policy.htm

• ClinicalTrials.gov

https://www.clinicaltrials.gov/

http://www.jpma.or.jp/about/basis/rinsyo/shishin09.html

http://www.umin.ac.jp/ctr/UMIN-CTR_Policy.htm

https://www.clinicaltrials.gov/


84

7. Publication

7-3Study reporting guidelines for paper preparation

(CONSORT Statement, STROBE Statement)

Reason to

learn



important to understand paper preparation guidelines (CONSORT Statement,

STROBE Statement).

What to learn• Basic principles of paper preparation guidelines (CONSORT Statement,

STROBE Statement).

How to learn/

Available tools



References

• CONSORT Statement

http://www.consort-statement.org/ (Japanese version available)

• STROBE Statement

http://www.strobe-statement.org (Japanese version available)

http://www.consort-statement.org/

http://www.strobe-statement.org/

8. THERAPEUTIC AREA/PRODUCT

KNOWLEDGE

85


86

8. Therapeutic Area/Product Knowledge

8-1 Disease/Diagnosis/Treatment

8-2 Knowledge on the Company’s own/Competitive Product

8-3 Knowledge on Related Drugs for the Designated Therapeutic Area

8-4General Knowledge of Medicine/Pharmaceutical Science/ Healthcare

System

8-5 Company Strategy

Overview

To internally/externally promote proper use of products, optimization of product value, etc. from a

medical/scientific perspective, a high level of medical/scientific expertise and knowledge on the

designated therapeutic area/product is required.


87


8-1 Disease/Diagnosis/Treatment

Reason to

learn

• High level of medical/scientific expertise and knowledge on the designated

therapeutic area/product are required to promote proper use of products,

optimization of product value, etc. from a medical/scientific perspective through

discussion with KTLs/KOLs and internal stakeholders.

What to learn

• Expertise and knowledge on disease/diagnosis/treatment in the relevant area to

discuss with KTLs/KOLs from a medical/scientific perspective

• Ability as an expert in the designated therapeutic area to provide

balanced/objective input and feedback to internal stakeholders from a medical

perspective

References • Diagnosis/treatment guidelines issued by relevant medical societies


88


8-2 Knowledge on the Company’s own/Competitive Product

Reason to

learn

• A high level of medical/scientific expertise and knowledge on the drugs in the

designated therapeutic area is required to promote proper use of products,


exchanges with KTLs/KOLs and internal stakeholders.

What to learn

• Expertise and knowledge on the company’s own products/competitive products

in the designated therapeutic area to provide balanced/objective information to

KTLs/KOLs and to discuss with KTLs/KOLs from a medical/scientific

perspective


balanced/objective input and feedback on company’s own products/competitive

products to internal stakeholders



89


8-3 Knowledge on Related Drugs for the Designated Therapeutic Area

Reason to

learn

• A high level of medical/scientific expertise and knowledge on related drugs in

the designated therapeutic area is required to promote proper use of products,


exchanges with KTLs/KOLs and internal stakeholders.

What to learn

• Expertise and knowledge on related drugs in the designated therapeutic area to

discuss with KTLs/KOLs from a medical/scientific perspective


balanced/objective input and feedback on related drugs to internal stakeholders



90


8-4General Knowledge of Medicine/Pharmaceutical Science/

Healthcare System

Reason to

learn

• Basic medical/pharmaceutical knowledge and knowledge of the Japanese

healthcare system are required to promote proper use of products, optimization

of product value, etc. from a medical/scientific perspective and to contribute to

identification and solving of unmet medical needs.

What to learn • Basic medical/pharmaceutical knowledge (non-clinical and clinical)

References

• Books on diseases/clinical pharmacology/pharmaceutical science

• Healthcare system-related websites of public organizations including the

Ministry of Health, Labor and Welfare


91


8-5 Company Strategy

Reason to

learn

• It is required to understand the company’s policy, Medical Plan, portfolio, and

target LCM in order to promote proper use of products, optimization of product

value, etc. from a medical/scientific perspective through exchanges with

KTLs/KOLs and internal stakeholders.

What to learn• Activities according to the Medical Plan and their significance

• Direction and strategic areas of the company from a long-term perspective

9. BUSINESS SKILLS OF MSL

92


93

9. Business Skills of MSL

9-1 Communication

9-2 Provision/Collection/Analysis of Information

9-3 Project Management

9-4 Business Manners

9-5 Presentation

Overview

It is important to acquire business skills to demonstrate high quality performance in the business

environment as MSL.


94


9-1 Communication

Reason to

learn

• A high level of communication skills is required in order to ensure smooth and

effective communication with people of diverse backgrounds including

KTLs/KOLs who are external customers and internal/external stakeholders.

What to learn

• Understanding of definition and significance of communication; acquisition of

basic knowledge and skills of communication in a systematic manner

• Effective communication with KTLs/KOLs and internal/external stakeholders,

correct understanding of other’s intentions, elicitation of opinions


95


9-2 Provision/Collection/Analysis of Information

Reason to

learn

• Analytical skills to identify high-quality unmet medical needs and insights based

on findings obtained through scientific exchanges with KTLs/KOLs and

information gathered from public sources are required.

What to learn

• Acquisition of basic knowledge/skills associated with factors and steps required

for collection/analysis of information

• Ability to organize and analyze information obtained through scientific

exchanges with KTLs/KOLs to summarize and turn it into truly useful insights

• Ability to prepare reports as appropriate materials based on the summarized

information


96


9-3 Project management

Reason to

learn

• MSL is required to proactively manage their activities from planning, progress

management to stakeholder management.

What to learn

• Acquisition of basic knowledge/skills of project management in a systematic

manner to successfully achieve the goals

• Development of activity plan, progress management, and risk management in

accordance with the Medical Plan on his/her own

• Collaboration and establishment of productive relationship with related

departments to effectively implement MSL activities


97


9-4 Business Manners

Reason to

learn

• As MSL who meet external customers as a representative of the company, it is

essential to show good business manners to build a trustworthy relationship.

What to learn • Basic manners/etiquette as an independent member of society


98


9-5 Presentation

Reason to

learn

• Acquisition of presentation skills is required to provide medical information to

KTLs/KOLs in an effective manner and to appropriately provide feedback on the

obtained findings to the relevant departments.

What to learn

• Acquisition of basic skills to plan/implement convincing, effective presentation in

a systematic manner

• Ability to correctly communicate medical information to KTLs/KOLs

• Feedback on the appropriately identified unmet medical needs and insights to

internal stakeholders and sharing of high-quality information

msl recommendation recommendation_2017 japhmed_en.pdf · (ktl/kol engagement, etc.) medical...

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