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ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

TOPRA MSc/Diploma Module 10

Management in Regulatory Affairs

Liz Gifford, Director, Global Regulatory Affairs, Eisai Ltd

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l To understand the skills needed to set up and run a successful Regulatory Affairs department

Learning Outcomes

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l Building the Regulatory Affairs department structure

lManaging resources, including time, staff and budget

l Preparation for meetings, audits, inspections

lMeasurement of performance of the RA department

In this presentation we will cover

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• What am I responsible for ?

• What are my objectives?

• What resources do I have/need to achieve the above?

• How will I organise my group?

• How will I demonstrate our value/show we are successful?

Congratulations, you‘ve got the job.....

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Typical activities and responsibilities

• Product and Project work

• Department structure• People management

and performance appraisal

• Training/develop-ment

• Resource planning

• Recruitment• Budget• Networking• Inspection readiness• Compliance• Company policies

and SOPs

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Department Structure

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Consider

Nature of Company

Size of Depart-

ment

CustomersBusiness Alignment

People

•Experience•Capabilities•Development opportunities•Secondments•Solid/dotted line reporting

•HQ /Affiliate• Generic• CRO• Start-up

• Functional groups• CMC• Nonclinical• Labelling / Post-

Marketing support

• Early development

• International• Support functions

• Operations• Reg. Intelligence

• Therapeutic groups•Sales and marketing•Manufacturing•R and D•Regulatory Authorities

•Therapeutic•Geographical

Department Structure

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Identify priorities, essential vs. nice to have, e.g. core groups / support

groups, what can be shared, what is done by

HQ/CROs etc

Benchmark other companies, obtain

feedback from within -what does/doesn’t work

Implement hierarchy according to dept need,

staff experience and skills. Support with

coaching/mentoring. Dedicated line managers,

or player/managers

Outsourcing to CRO vs. in-house. Less resource but

not building in-house expertise. Consider

temporary or permanent staff, ad-hoc consultancy.

Clearly define roles and responsibilities,

expectations. Task specialist or product

specialist

Systems and Processes Structure• Document management, Publishing,

templates• Records and archiving• Commitment and safety-related tracking• Work planning and reporting• Training and compliance• Policies, SOPs, Standard Working Practices• Regulatory Intelligence

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Resourcing a Project

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Communicate, agree, delegate,

motivate, inform, enable

Plan, prioritise,

check, measure, review, adjust

Complete, review, report,

praise, thank

• Look at existing priorities, resource and skills

• Identify project managers vs. technical experts

• Don’t be afraid to move people around

• Consider stretch assignments, but ensure support is in place – don’t set people up to fail

• Consider secondments from HQ/Affiliates

• Permanent hire vs. consultants

• Provide incentives and rewards!

Resource Models

• Develop process flows and resource models for standard tasks

• How long should an activity typically take?

• How many tasks can an individual manage?

• Keep an overview of what staff are working on, and deadlines

• Enables you to effectively balance workload, compare performance (and reward, praise)

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Time Management

• Set time aside for tasks – no email!

• Be realistic about how long things take

• Prepare for meetings• Follow up on actions• Be available for your

staff

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Performance Management

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Performance Management

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• Read, understand and follow company procedures•Beginning of the year:

•Set SMART objectives, according to business needs•Agree a personal development plan based on gaps in knowledge and/or skills•Identify suitable training courses (internal and/or external)•Consider coaching/mentoring e.g. for high potential staff taking on more responsibility

•Mid-year•Review progress against objectives, if not on track why not?

•If different priorities, revise objectives•If difficulties, discuss and put closer monitoring in place

•End of year•Obtain feedback on performance against objectives and core role competencies•Important to encourage honesty (like, dislike and do differently)•Be consistent and transparent when ranking

Measurement of Performance

• Achievement of goals/objectives• Quantify work output• Quality of work• Issue management• Key Performance Indicators – what do your

stakeholders value? 360° feedback• Demonstrate quality, improvement

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Managing poor performance

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Verify:Obtain full and

adequate feedback360 ⁰ review

Identify Cause:Lack of support,

under-resourced; orCompetency issue

Solve:Support with coaching/mentoring/change

reportingMonitor closely, set short term objectives

Hold regular prioritisation meetings; review projects as a group; share learnings

Work with HR; put warnings in place and follow strictly the process through to outcomeOut-source work, bring in consultant

Interviewing

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• Job specification: title and summary of role, position in company, reporting structure, duties

•Personal specification: knowledge, skills, essential vs. desirable

Job Description

•What do you need to know from the candidate vs. what other interviewers will cover, avoid repetition – work with HR

•Ask open ended questions based on key role competencies•Allow candidates time to think and speak, but keep control

Understand your role as interviewer

•What type of personal qualities are needed for the job•What mix of personalities do you already have in the department – aim for balance

•Don’t be afraid to hire new graduates for junior positions

Consider the person not just the CV

Accurate forecasting critical but challenging. Many companies want within +/- 3-5%. Review frequently with finance.May be linked to your performance objectives and therefore your pay rise/bonus!

Important for planning, deciding between competing priorities, making informed decisions, knowing when plans are going adrift, communicating financial decisions to senior mgt, benchmarking..

Consider carefully: salaries, travel, anticipated filings, scientific advice, training, external consultancy, IT, etc...Identify what will be spent, not what should be spent

Budget

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Team Meetings

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• Agenda driven

• Regular schedule, rotating chair?

• Information sharing, to agree common position

• Focus topics – invite other departments to learn from and educate

• Issues/hot topics

• Celebrate achievements, acknowledge success

• Capture actions and distribute according to resource, capability, development opportunity etc.

• Decisions should be documented

Cross-Functional Strategy Meetings

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Define Regulatory

responsibilities

Provide strategic input

Work collaboratively

• Liaison with Agency• Anticipate Qs and

prepare Q&A

• Relevant Guidelines• Knowledge of

Agencies• Precedents• SWOT analyses

• Business –label devt.• Clinical – proposed

studies • Safety – labelling,

risk management• All: define questions

Inspection and Audit

• GCP, Pharmacovigilance, GMP, Internal Audit

• Product specific, routine systems, for cause

• Identify core procedures for regulatory affairs and ensure you have up to date SOPs and SWPs – and that your department is working to these procedures (compliance)

• Prepare SOPs/SWPs for any critical processes that currently do not have appropriate procedures in place - before the inspection!

• Ensure that any follow up measures from the previous inspection are fully completed or that an action plan is in place and on track – Corrective and Preventative Actions (CAPAs)

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Inspection Preparation

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Identify Project

Manager

Pre-inspection

dossier

SOPs / WIs

Understand the process

Interviews

• List of CTAs, MAs• Organograms• SOPs• Key contacts• Facilities• Key service providers

• Identify key SOPs e.g. • tracking –

submissions, approvals, commitments

• Handling of AEs/SAEs

• Interactions with CROs – contracts and agreements, document management

• Supply chain –release, recall

• Look on agency website – MHRA good example.

• Consider if country legislation applicable as well as EU (e.g. UK SIs).

• Consider consultant for advice

• Select potential interviewees

• CV, job description, training record

• Conduct mock-interviews

What does a successful RA manager look like?

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• Communicates well across all levels of the organisation

• Motivates, challenges, develops and supports their team to achieve their goals

• Gains the respect and confidence of other departments and external customers

• Offers well constructed strategic advice and brings creative solutions to problems

• Keeps calm under pressure and keeps others on track

l Building the Regulatory Affairs department structure

l Managing resources, including time, staff and budget

l Preparation for meetings, audits, inspections

l Measurement of performance of the RA department

In this presentation we covered

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QUESTIONS?

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AcknowledgementsStella Andrews (Roche)

Contact details

Name: Liz GiffordTel: 0845 676 5176Email: liz_gifford@eisai.net

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