2015 EDUCATION PROGRAMS

The Pharmaceutical Education & Research Institute, Inc.

PERI’s MISSION:

- To optimize the effectiveness of those involved in the development, review and approval processes for health care products through our education and training programs; - To foster professional growth through training and the sharing of information and knowledge in

the research, development, manufacturing, marketing and post-marketing surveillance of health care products; and - To enhance the professional effectiveness of our constituencies by providing training and

accredited continuing education for physicians, nurses, pharmaceutical professionals and others, that meets or exceeds established standards.

Adopted by the PERI Board of Directors in November 2000.

PERI’s BOARD OF DIRECTORS:

William J. DeLorbe, PhD Chairman Vice President Human Resources Pharamcopeia Jonca Bull Vice President US Drug Regulatory Policy Novartis C. Robert Eaton President and CEO Your Bio Team David I. Goldsmith, MD President & Senior Consultant Goldsmith Pharmacovigilance & Systems

Judith K. Jones, MD, PhD President PERI, Inc. Anthony J. Piraino, MD, PhD, FACP Senior Director Clinical Research AstraZeneca Pharmaceuticals, L.P. Jean-Louis Saillot, MD President JLS Pharma Consulting Claudio P. Spiguel, PhD Adjunct Professor Alfred Lemer College of Business and Economics University of Delaware

Gillian R. Woollett, MA, D.Phil Vice President, FDA Regulatory Policy Avalere Health

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PERI 2015 COURSE CATALOG: TABLE OF CONTENTS

CONTINUING EDUCATION

CORPORATE EDUCATION

OPEN COURSES

DISTANCE EDUCATION

Introduction Mission Statement 2 Board of Directors 2 Message from the President 4 Certificate Programs 5 Continuing Education 5

Corporate Education Programs 6 Webinars & Blended Education 7 Program Topics ▪ Fundamentals Programs 8 ▪ Oncology 8 ▪ Quality Assurance/Compliance 9 ▪ Project Management 9 ▪ Clinical Research & Development 9 ▪ Regulatory Affairs 10 ▪ Customized Programs 11

Open Courses 12 Scheduled Courses ▪ Project Management 13 ▪ Labeling Webinar Series 14 ▪ Basic Drug Development 15

Distance Education 16 Program Topics ▪ Applied Good Clinical Practices (GCP) 17 ▪ Clinical Monitoring & Site Management 18 ▪ Current Good Manufacturing Practices 19 ▪ Decision Points in Drug Development 20 ▪ Regulatory Context for Conducting 21 Clinical Trials ▪ Implementing a Clinical Trial Program 22 ▪ Ensuring Subject Protection & Scientific 23 Integrity ▪ Pharmacology Online 24 ▪ Statistical Concepts Used in Clinical Trials 25

Archived Webinars 26 Project Management Series 26

Complete Registration Policies 27 Registration Form 28

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MESSAGE FROM THE PRESIDENT The Pharmaceutical Education and Research Institute (PERI) is pleased to present the new Spring 2015 Catalog of our Open, Corporate Education and Distance Education courses. We are now in our 25th year of providing accredited education to professionals in the global biopharmaceutical and medical product sector. To assure that our education tracks to industry initiatives, PERI works with faculty and committees to survey the continually changing terrain facing professionals. This is an exciting new era marked by a burgeoning array of scientific developments—biomarkers, personalized medicine with the application of genomics, new vaccines, and drug-device combinations to name a few. This is coupled with changes in the shrinking global regulatory environment. As new scientific developments, regulations and policies emerge, the need for a well-informed and updated workforce grows. PERI strongly believes that education for this sector’s professionals is critical to support the rapid advances in this area of applied, regulated science. Today, education is an expected part of professional development to assure a company’s competitive advantage in the world marketplace. The global economic environment challenges make both corporations and individuals sensitive to value in education. PERI is proud to have been on the forefront in addressing this core requirement. PERI is also somewhat unique in that our courses require active participation and problem solving. This feature distinguishes our format from the more passive lecture or webinar, and we believe it is an important strength of our programs. In addition to our core education courses, PERI is prepared to meet our learners’ diverse needs by offering more specialized subjects, including more one-day special topic courses and targeted webinars. New topics are being added throughout the year Please check our web site, http://www.peri.org for the latest information. We at PERI are committed to providing programs that provide timely knowledge taught by experienced and knowledgeable faculty. We are always interested in hearing from those of you who would like to serve as faculty or developers of new courses. On behalf of all the PERI Staff, our Board and many supportive faculty, thank you for your interest! We hope you will have an opportunity to take one or more courses this year. Thanks and we look forward to meeting you at a course in the coming months! Sincerely, Judith K. Jones, MD, PhD President, PERI

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CONTINUING EDUCATION CREDITS

PERI is pleased to make continuing education credit available to you for participation in Corporate Education Programs, both on-site and online. Applying for credit is simple! To receive credit, you must participate in the entire program, and submit a Continuing Education Application.

To receive credit for an online Distance Education (DE) course, you must complete all course requirements (i.e., quizzes and/or case studies), complete the program evaluation, and submit an email request for DE credit. Your Continuing Education Certificate will be mailed upon course completion.

PERI, Inc. is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Note: Please check our web site for the most current information on our continuing education offerings.

PERI CERTIFICATE PROGRAMS

Document your professional development and education with PERI’s Certificate Programs. These education tracks are specifically and expertly designed to enhance the knowledge and skills needed for your particular job function.

Select the Certificate Program that best matches your professional development needs: Basic Research, Clinical Sciences, Project Management, Safety Labeling or Quality Assurance/ Compliance. Choose the PERI courses you wish to attend from the core and elective courses listed within each program. You must individually register for each program you wish to attend independently of the certificate program application.

When you have completed the online application, as well as the number of required courses, notify PERI’s registration office when you have completed the curriculum. Upon confirmation of completion, your certificate will be mailed to you! There is no additional cost (beyond the course registration fees) for you to enroll in any PERI Certificate Program.

For in-depth information and program requirements for PERI’s certificate programs, please visit our website at http://peri.org/peri-certificate-programs/

Information found in this catalog is current as of March 2015. Please check the PERI website for up-to-date information.

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CORPORATE EDUCATION PROGRAMS

PERI’s Corporate Education Programs are delivered directly to your company at your facility, and can be tailored to your company’s specific educational needs and objectives. For more than 10 years, PERI has been providing the highest level of on-site education to the pharmaceutical, biotech and medical device industries.

PERI’s Corporate Education clients include over 350 pharmaceutical, biotechnology and government organizations. Check our website at

www.peri.org for updates on all our course offerings.

PERI Corporate Education Programs are… Cost Effective: You can save time and money by having

PERI train a group of 15 or more team members at the location of your choosing. Reduce travel expenses, time away from work and more with training on-site or at a nearby location.

Customized Programs Developed By Expert Faculty: Courses are designed to address the specific needs of your company by expert PERI faculty, many of which have years of industry and educational experience.

Additional Features & Benefits: - PERI’s open courses are available

to corporate education clients for customized group education

- Discounts are available for multiple courses

- Programs can be offered to virtual audiences via webinar/webcast

- Programs can offer continuing education credits for Physicians, Pharmacists and others

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PERI’s Customized Webinar/Webcast and Blended Education Programs In addition to on-site training with PERI staff and faculty, consider adding webinars and webcasts to your curriculum! Customized blended-education programs are available to supplement live learning and enhance the training experience. Combining webinars/webcasts with live learning also helps reduce program expenses! Topics Include: - Overview of Biopharmaceutical Development - Cancer 101 - Toxicology for Non-Toxicologists - Good Clinical Practices - Postmarketing Safety Reporting - Data Monitoring Committee - Imaging Approaches to Oncology Drug Development - PIP (Pediatric Investigation Plan) - Risk Management: EMA Perspective - Biosimilars: Development Considerations and

Current Regulatory Environment - Drug Labeling - Statistics 101 - Pharmacoeconomics - Global Pharmacovigilance - Cancer: Pathophysiologies - Drug and Biologics Manufacturing - Overview of Prescription Drug Labeling Regulations - And Many More!

Student Testimonials Here’s what PERI participants are saying:

On Cancer 101: “I can now begin to work in oncology with a baseline understanding of the therapeutic area.”

On Clinical Development: “Invaluable course, especially for first time researchers.”

On Clinical Trial Management: “This course helps me to better understand the development and correct documentation for all the agencies that monitor clinical trials.”

On Drug Development: “Love the workshops! Excellent activities and follow-up discussions. I learned that it is not easy to manage a portfolio because of all the elements you must consider.”

On Global Regulatory Affairs: “I can now interact more effectively with regulatory affairs experts in different regions.”

On Good Clinical Practices: “A great refresher for prior GCP courses; gives a broad picture about clinical trials.”

On Project Management: “Honestly, the best and most useful of all the courses I have taken with PERI!! I found some things to try on my research-phase project, i.e., how to approach timelines and how to address the pushback on the ‘you can’t predict science’ mindset.”

On Regulation of Marketing: “I am better able to medically review promotional pieces with an understanding of FDA and DDMAC’s perspectives.”

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Fundamental Training Programs Decisions in Drug Development: Portfolio Management Workshop is a highly interactive, hands-on learning experience! This 4-hour workshop provides an overview of the processes and challenges common to all new development products, basic drug development steps and ideal characteristics of a development candidate. Interactive workshops will then follow the development of a drug from discovery to product label development.

Drug Development: Overview of Biopharmaceutical R&D provides an overview of the processes and challenges common to all product development projects. Interactive workshops will follow the development of a drug from discovery to product label development.

Biologics Product Development provides an overview of the processes and problems common in Biologics development. Participants will understand development decision points from initial identification to post-approval monitoring.

Medical Devices: Demystifying Regulation and Guidance provides an overview of safety considerations of medical devices. This course identifies critical definitions, classifications and device categories.

Pharmacology Concepts provides an intensive overview of pharmacology, including the principles of pharmacodynamics and pharmacokinetics. A general introduction to selected therapeutic areas is also included, and can be tailored to your company’s area of specialty. Specific courses are also available on Pharmacokinetic Concepts and Applying Pharmacokinetics and Pharmacodynamics.

Oncology Cancer: Introduction to Oncologic Product Development is designed to cover oncologic clinical trial design from Phase I through Phase III. In addition, the course provides an overview of human cancer pathophysiology and current therapeutic issues relevant to the client’s specific development areas. Also available is Cancer 101: A Basic Overview of Oncology Drug Development, which provides a foundation for new oncology researchers.

SPOTLIGHT FUNDAMENTAL COURSE Drug Development Decisions: The NDA Simulation provides a better understanding of the drug development and regulatory processes by simulating a "company project team" working together to get their "drug" approved with the required label and within projected timeline and budget. The initial portion of the course provides didactic presentations, which provide the groundwork for the IND and NDA Game simulations.

CORPORATE EDUCATION COURSES

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Oncology Development: Overview for Market Planning provides an introduction to the cancer disease process and an overview of treatment method categories for the purposes of market planning. Also discussed is an overview of the design of oncology clinical trials and the approval process of oncology drugs. Specific cancer therapeutic areas can be tailored to client’s needs.

Quality Assurance and Compliance Clinical Monitoring: Essential Concepts presents an overview of clinical monitoring in the context of the overall drug development process, FDA regulations and International Conference on Harmonization (ICH) guidelines for Good Clinical Practices.

Good Laboratory Practices addresses regulatory compliance principles relative to the FDA’s current Good Laboratory Practices (GLP) regulations. Topics include: development of GLPs, roles and responsibilities of key staff members, SOPs, laboratory facilities, and computer validation issues.

Project Management and Leadership Development Project Management and Leadership Strategies for Pharmaceutical Scientists focuses on improving the leadership skills of project leaders and mid-level line managers who work in an environment that requires collaboration in order to be successful. The program uses an analytical model of leadership that is readily accepted by technically oriented people.

Clinical Research & Development Asthma and COPD: Clinical Drug Development provides a comprehensive overview of asthma and COPD as a basis for developing new drugs to more effectively treat these diseases. Pulmonary physiology, pulmonary physiology testing, current treatment approaches, and a review of regulatory policies in this area will be used to discuss recent approaches to developing new drugs for asthma and COPD.

SPOTLIGHT QUALITY ASSURANCE COURSES Good Clinical Practices and Advanced GCP provides a background in Good Clinical Practices (GCP) as applied to clinical trials conducted worldwide. The Advanced course focuses on GCP auditing techniques and strategies, providing in-depth application-oriented experiences.

SPOTLIGHT ONCOLOGY COURSE Intermediate and Advanced Concepts in Oncologic Product Development is designed to cover oncologic clinical trial design considerations and regulatory issues. Topics include: Clinical trial management operational issues, chemoprevention, angiogenesis inhibitors, new imaging approaches, and cancer pathophysiologies.

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Cardiovascular Product Development provides an overview of advances in cardiovascular drug development. Topics include anatomy and physiology associated with hypertension, coronary disease, heart attack, and heart failure; coronary and peripheral artery disease, thrombosis, and anticoagulation, cardiac arrhythmia and clinical trial methodology are discussed. Topics on cardiac-related medical devices can also be included.

Clinical Trial Management and Operations addresses trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry. The course presents a variety of topics on trial planning, operational aspects, organizational tips, resource planning ideas, financial implications, timeline concerns, regulatory implications, communication, and team building.

Clinical Investigator Training instructs practicing physicians on the basics of planning and implementing clinical research trials. Topics can be tailored to provide information on specific disease states, protocols and other company-specific details.

Regulatory Affairs Global Regulatory Affairs provides participants with an overview of the laws, guidelines and regulations governing the development and registration of prescription pharmaceuticals outside of the United States. Regions specific to our client’s needs are covered.

Global Pharmacovigilance focuses on introductory concepts of global regulatory requirements in drug safety. Topics include MedDRA, basic epidemiological issues, signal detection and risk management.

Regulation of Marketing and Promotion of Prescription Drugs addresses current laws, guidelines and regulations governing the marketing and promotion of prescription drugs and biologic agents. An overview course on Prescription Drug Labeling Regulations is also offered. Regulatory Inspections: Preparation and Practice describes the necessary steps in preparing for a Regulatory Site Inspection. Key topics include current inspection issues, differences in inspections from global agencies, handling inspections and preparing for inspections. A mock “Site Audit” can be conducted as a practical exercise, followed by a debriefing of the inspection findings. Also available to audiences of varying experiences: Preparing for an Advisory Committee Meeting.

SPOTLIGHT CLINICAL RESEARCH COURSE Clinical Trial Management and GCP Essentials provides a foundation of GCP concepts, followed by a focus on auditing techniques and strategies, clinical trial management issues and skills needed effectively conduct trials in the fast-paced drug development industry.

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Additional Courses Available … Or Customize Your Own! - Oncology Development: Regulatory Considerations - Immunology - Vaccine Development - Pharmacology: Advanced Concepts - Product Launch - Managing Outsourcing to CROs - Managing Investigator Initiated Research - Effective Negotiations in BioPharma - Protocol Writing - SOP Development - Conducting Phase I Trials - Preparing for an Advisory Committee Meeting - US Regulatory Overview - Diabetes: Epidemiology and Pathologies - Metabolic Syndrome - CMC in the CTD - Filing IND, NDA, BLA - Clinical Data Management

FEATURED ONLINE LEARNING: Decision Points in Drug Development Decision Points in Drug Development provides an overview of the process and issues common to all new chemical entity (NCE) development projects, from the research and development through product launch and post-marketing safety. The course focuses on the decisions that need to be made throughout the development process and the criteria influencing these decisions. These decisions include identifying a lead, choosing a compound for development, conducting pre-clinical work, determining that drugs are safe in the clinic, establishing the dose, generating a label, and deciding to file an NDA. Customize course content, length, and format to suit the needs of your team. The course is structured with lectures and workshops, creating an interactive, engaging learning experience.

Corporate licensing is available for the distance education web-based module. Learners who participate in this introductory online self-study course should expect to spend about 5 hours to complete the course. This option offers participants the ability to participate at their own pace.

An Interactive Life Webinar can be recorded and/or streamed to employees around the world, allowing your team members to receive the same training regardless of location. Customize the program to focus on select topics or review the drug development process from a particular point of view. Webinars are available as 3- or 4-hour sessions.

Drug Development for Non-Scientists has been especially designed to enable personnel without a scientific background to understand the drug development process. The course is fully flexible, is offered as a one-day or two-day option.

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OPEN COURSES

For more than 20 years, PERI has offered educational opportunities to the pharmaceutical, biological, and medical device industries through its Open Courses. PERI

has exceeded a level of excellence through these courses by bringing firsthand knowledge and expertise from industry faculty. This perspective provides a valuable

benefit to students and is the trademark of PERI courses and workshops.

By attending a PERI Open Course, you will learn from faculty presentations, case studies, small group workshops, and personal interaction with the course directors and faculty. The second element to learning is the interaction that occurs with other course participants. Each Open Course offers networking possibilities with faculty and peers throughout the course. Maximize your source of news and information about the industry while enhancing the skills that you’ve already learned and put to use.

Course Descriptions The Open, Corporate Education, and Distance Education sections of this catalog describe the content of courses in each respective program. Individual description pages provide information pertaining to educational objectives, target audience, and key topics for Open Courses, as well as date, location, and registration fees. Please see PERI’s website for the most current agenda, faculty list and Course Manager contact information.

Registration Information • You may register by mail, phone, or through ourwebsite at www.peri.org. For mail, please submit the registration form printed in this catalog (see page 28). • Submit your registration form with full payment to holdyour place in a program. Full payment must be received no later than 3 weeks prior to the course start date. • You may pay by company check (payable in U.S. dollarsto PERI, Inc.) or credit card (VISA, MasterCard, or American Express). We regret we cannot accept personal checks. We will email you a confirmation notice after processing your payment. • See page 27 for the complete registration policy.• PERI reserves the right to change faculty andpresentation times/schedule to accommodate situations beyond its control.

Registration Discounts (cannot be combined) Early Registration Discount Save up to $200 by

registering early! Look for early registration fees and deadlines listed in this catalog and on the course webpage.

Government and Academic Discount Employees from government and academic institutions may deduct $200 from the applicable registration fee for two- or three-day courses and $100 for one-day workshops.

Full-time College/University Students Check with the PERI registration staff for registration discount details.

Group Discount Register 3 or more people from the same company at the same time in the same course, and receive a 10% discount.

Referral Rewards Program Use our Referral Rewards Program to refer a colleague who has never attended a PERI course and we’ll send you a discount code worth $200 off any PERI Open Course. There is no limit to the number of people you can refer and the discount codes are transferable. Terms and Conditions apply. Email peri_education@peri.org for details.

See page 27 or visit our website for cancellation policies and procedures. For updates and additional information, visit our website www.peri.org.

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Project Management for the Pharmaceutical and Biotechnology Industries Course Dates: May 21-22, 2015 Regular Course Rate: $1595 This course addresses project management issues and skills needed to wisely choose and effectively develop new therapies in today’s global climate. Key concepts include managing drug development teams through major decision points during the stage-based drug development process, including organizational options team building, resource and budget planning, and R&D portfolio management. Educational Objectives Upon completion of this course, participants should be able to:

· Discuss the drug development process and key decision points · Define how to build more effective project teams · Plan and manage development programs · Apply the principles of financial planning · Identify project risks and develop contingency plans

Who Should Attend

· Project Team or Program Managers · Project Coordinators and Team Leaders · Clinical Research Directors · Pharmacists · Regulatory Affairs and R&D Professionals

Key Topics

· The Pharmaceutical Development Process and Environment

· The Art and Science of Project Management · Organizational Challenges and Opportunities · Financial Overview for Project Managers · Project Planning · Risk Management for Project Managers · Team Communications · Managing Alliance Project Teams

OPEN COURSES: SPRING 2015

Benefits of Attendance:

· Understand the activities and interdependencies of drug development

· Learn project management concepts and challenges

· Build more effective project teams

· Interact with industry professionals

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Working with Company Core Data Sheets and Core Safety Information Eight-Part Labeling Webinar Series – Runs Consecutive Wednesdays Course Dates: April 1, 8, 15, 22, 29, May 6, 13, 20 Course Time: 12:00 – approx. 1:30 pm ET Series Price (8 sessions): $1700.00 Individual Sessions: $250.00 For Spring 2015: Introducing a new interactive series for the labeling professional! Courses developed and taught by Dr. med. Leander Fontaine, Pharmiceutics LLC. This series of 8 webinars provides a solid foundation for professionals responsible for designing and maintaining the content of CCDS and CCSI, and for governing global implementation of core labeling. The course offers a unique opportunity to review systematically established best practices and how new developments (e.g., EU RMP Safety Specifications, US Pregnancy and Lactation Rule) affect what needs to be done in core and worldwide labeling. The course modules build on each other. It is highly recommended to attend the course in its entirety. Session 1: Introduction This session addresses how to govern global labeling with a Company Core Data Sheet (CCDS) and process requirements. Session 2: The CCDS as a Document This session addresses the essential features and associated business rules, as well as the meaning of Company Core Safety Information (CCSI). Session 3: Populating the Adverse Reactions Section of the CCDS – Part 1 This session addresses the definitions of adverse reporting and evidentiary standards for adding adverse reactions to CCSI. Session 4: Populating the Adverse Reactions Section of the CCDS – Part 2 This session addresses how to identify adverse reactions from clinical trials and illustrating the frequency in local labeling. Session 5: Contraindications and Warnings and Precautions in a CCDS This session addresses contraindications, elevating information to Warnings and Precautions and US FDA guidelines. Session 6: Other Safety Information in a CCDS This session addresses additional safety information found in the CCDS, including interactions and preclinical safety data, as well as pregnancy, lactation and fertility in a CCDS. Session 7: Other Key Information in a CCDS This session addresses additional information in the CCDS, including indications, dosage and administration, clinical pharmacology, clinical trials, excipients). Session 8: Development Core Data Sheets and Development Core Safety Information This session addresses when labeling activities should begin and compares the CCSI and DCSI.

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Basic Drug Development: From Molecule to Market Course Dates: May 7-8, 2015 Early Bird Deadline: 03/20/15 Regular Course Rate: $1595 Early Bird Rate: $1395 In a blending of online and live learning, this course provides an overview of the process and issues common to all new chemical entity (NCE) development projects, from the research and development stages through product launch and post-marketing safety. The course focuses on decisions that need to be made throughout the therapeutic development process and the criteria influencing these decisions. The online component is PERI’s Decision Points in Drug Development. Educational Objectives Upon completion of this course, participants should be able to:

· State the basic steps in the drug development process · Explain the difference between research and development · Discuss the key decision points in the drug development process · Explain the implications of label-based drug development · Discuss the role of interaction with FDA and other regulatory agencies

Who Should Attend

· Professionals new to drug development · Scientific and non-scientific staff members at all levels · Members of clinical research teams · Pharmacists · Medical writers and communication specialists · Project managers and regulatory affairs personnel

Key Topics

· Non-Clinical Drug Development · Decision Points in Drug Development · Regulatory Review Process (FDA, EMA) · Portfolio Review · Meeting with Regulatory Agencies · Drug & Biologic Product Manufacturing · Clinical Trial Design · Safety in the Drug Development Process · Global Considerations in Drug Development · Panel Discussion with FDA Representatives: Putting It All Together

Benefits of Attendance:

- Identify the basic steps in drug development

- Gain hands-on experience through practical drug development workshops.

- Understand team responsibilities in pharmaceutical development

- Learn key aspects and updates in the regulatory process for US, Europe and Japan

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DISTANCE EDUCATION

Have restrictions on travel? Can’t get away from home or office? Have a limited training budget? Need training right now?

PERI brings the classroom to you! It’s only a click away... What You Can Expect PERI’s distance education courses have been designed as self-study learning activities that are delivered completely over the Internet. Courses include the following features and tools:

· Comprehensive course content written by expert faculty from industry, the FDA, and academia · Bookmark function to hold your place in the course · Online reference links · Common industry abbreviations and acronyms · Glossary of terms

· Exercises and case questions · Self-assessment quizzes

Benefits of Web-Based Courses · Save Time - Save time you might otherwise have spent traveling. · Save Money - Eliminate travel costs and take advantage of lower registration fees. · Convenience - Take a class when you need it, not when it happens to be offered. · Flexibility - Learn at a place and pace that best suit you and your schedule. · Validation - Demonstrate knowledge gained through self-assessments.

Corporate Licensing of Distance Education Courses Packages for distance education courses are available for companies to train groups of 20 or more individuals. Corporate licensing offers numerous benefits, including: • Significantly reduced per-student registration fees • Access to reports on student progress • Easy training of global staff • Pre-payment options • Data sharing with Learning Management Systems Registration Discounts/Cancellation Policies After submitting registration, you will receive email notification of course access as soon as payment is confirmed. Registrations will not be processed without full payment.

Academic/Government Discount: Employees from government and academic institutions are eligible for a $100.00 discount on web-based courses. Full-time college/university students should check with PERI registration staff for discount details.

Group Discounts: Register more than 4 employees from the same company at the same time and receive the 5th registration free. Cancellation: All cancellation or replacement requests must be made in writing, via fax 571-490-8408, attention: Registrar/Distance Education or email registrar@peri.org. No requests made via telephone will be honored. You may cancel your registration or transfer your registration to a co-worker if you have NOT accessed the course. Refunds for cancellations will be issued less a $100.00 enrollment fee. Once you have accessed the course for any amount of time, cancellations and transfers will not be issued. Extensions: If you are not able to complete the distance education course in the time allotted, you may request an extension. Requests for an extension must be made in writing, and there will be a fee of $100.00 for every 30 days of extended access.

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Applied Good Clinical Practices (GCP) Course Rate: $590 Access Length: Four (4) Months Course Length: Approximately 15 hours of study time to complete this course This course will provide you with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. The curriculum will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives, including those of the sponsor-monitor and the quality assurance group, institutional review boards (IRB)/ethics committees (EC), and the clinical investigators. GCPs will be discussed from the regulatory perspectives of FDA and ICH. Educational Objectives Upon completion of this course, participants should be able to:

· Interpret FDA regulations and International Conference on Harmonization (ICH) guidelines pertaining to GCPs.

· Identify the regulatory, source documentation, and recordkeeping requirements for clinical trials.

· Describe the components of internal auditing systems. · Explain the roles and responsibilities of sponsor, monitor, investigator, and regulatory

authorities in ensuring the proper conduct of clinical trials. · Apply GCP principles to the collection and reporting of adverse events.

Who Should Attend

· Quality assurance associates · Regulatory compliance professionals · Clinical research associates · Medical monitors · Pharmacists

Key Topics

· Institutional Review Board (IRB)/Ethics Committee Responsibilities · Regulatory Environment in the US · International GCP Regulations · Investigator Responsibilities · Sponsor Responsibilities · The Protocol

· Sponsor Obligations · Monitoring Responsibilities · Clinical Quality Assurance (CQA) Group · FDA Inspections · Managing FDA Inspections

DISTANCE EDUCATION PROGAMS

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Clinical Monitoring and Site Management: The Fundamentals Course Rate: $590 Access Length: Four (4) Months Course Length: Approximately 12 hours of study time to complete this course The goal of this course is to provide a practical orientation to site management and monitoring of clinical studies. The course provides a comprehensive overview of clinical monitoring in the context of the overall drug development process; FDA and HPB regulations; and ICH guidelines for GCP. The course combines text-based study materials with interactive exercises enabling you to apply what you have learned to on-the-job situations. Educational Objectives Upon completion of this course, participants should be able to:

· Identify the regulatory basis for monitoring clinical research activities. · Plan site management and clinical monitoring responsibilities from study initiation to study

completion. · Describe compliance with informed consent procedures. · Define key steps in maintaining the integrity of trial data. · Analyze trial-related documents. · Outline reporting requirements for adverse events.

Who Should Attend

· Clinical research associates new to the industry · Study coordinators · CRA supervisors · Pharmacists

Key Topics

· The US Regulated Environment · The HPB Regulated Environment · Informed Consents · Investigator Selection · Study Initiation / Investigator Meetings

· Drug Accountability · Sample Handling · Site Management / Visits · Data Management · Quality Assurance

· What is an Adverse Event (AE)? · What are the Reporting Requirements of AEs?

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Current Good Manufacturing Practices (cGMP) Course Rate: $199 Access Length: Two (2) Months Course Length: Approximately 5 hours of study time to complete this course The goal of this web-based course in Current Good Manufacturing Practices (cGMP) is to provide an introductory level discussion of the legal principles supporting cGMP, tools and resources necessary for implementation, an overview of cGMP requirements, including biologics and Biosimilars, and an explanation of what FDA will evaluate at the manufacturing site. Educational Objectives Upon completion of this course, participants should be able to:

· Describe the legal principles of cGMP including what constitutes non-compliance, the legal scope of inspections, and exclusions from cGMP.

· Identify CGMP implementation tools. · Discuss the status and applicability of cGMP regulations, as well as define key terms contained

in the regulations. · Explain what the Office of Manufacturing Product Quality (OMPQ) of FDA will evaluate at a

manufacturing site. Who Should Attend

· Chemists · Engineers · Plant Operators and technicians · Quality Control Specialists · FDA Reviewers · FDA Project Managers

Key Topics

· Legal Principles · Implementation Tools · Regulations · Drug Manufacturing Inspections Program · Biologics and Biosimilars

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Decision Points in Drug Development: Discovery to Launch Course Rate: $415 Access Length: Two (2) Months Course Length: Approximately 5 hours of study time to complete this course This introductory web-based module focuses on critical decisions that are made throughout the development of a new chemical entity as the process evolves from discovery to first in humans and ultimately to launch. These decisions include identifying a lead, choosing a compound for development, conducting pre-clinical work to assess which drugs should go to clinic, determining that drugs are safe in the clinic, establishing the dose, generating a label, and deciding to file an NDA. A key element of the module is a discussion of how the product label drives the drug development process. The difference between an activity-based and a knowledge-based drug development process is also addressed. Educational Objectives Upon completion of this course, participants should be able to:

· Differentiate between traditional and contemporary knowledge-based drug development processes.

· Describe each knowledge-based phase of the drug development process with a focus on safety and effectiveness.

· Explain the value of a "label-driven/question-based" approach to drug development. · Define critical decision points in the clinical candidate selection, development and

regulatory review processes. · Utilize the questions and critical decision points to design a question-based drug

development plan. Who Should Attend

· Individuals from any discipline new to drug development. Key Topics

· History of Drug Regulation: Who Regulates and Why Contemporary, Knowledge-Based Drug Development as Compared to the Traditional, Activity-Based Approach

· Critical Drug Development and Review Decision Points · Successful and Failed Drug Development Programs

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The Regulatory Context for Conducting Clinical Trials Course Rate: $240 Access Length: Two (2) Months Course Length: Approximately 3 hours of study

time to complete this course This course is designed to interpret FDA regulations and ICH guidelines to apply to informed consent, adverse event and drug accountability reporting, ethical conduct during clinical research and to define the IRB/ED's. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines. Educational Objectives Upon completion of this course, participants should be able to:

· Interpret FDA regulations and ICH guidelines pertaining to GCPs · Apply GCP regulations and guidelines to your processes around informed consent, adverse

event reporting, records and reports, and drug accountability · Describe the IRB/EC responsibilities for ensuring the ethical conduct of clinical research

Who Should Attend

· Study site investigators · Site monitors and auditors · Research nurses · Regulatory affairs associates · Data management personnel

Key Topics

· Regulatory Environment in the United States · International GCP Regulations · Institutional Review Boards/Ethics Committees

This is the first course in the Good Clinical Practices for the Clinical Research Team Series. Series Description This course provides a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site- based investigator rather than the sponsor. This course provides an excellent tool for the training and education of all members of the sponsor and clinical research teams to insure their knowledge and understanding of the clinical research process and GCPs. Save when you bundle programs in series - all 3 courses for only $590!

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Implementing a Clinical Trial Program Course Rate: $320 Access Length: Two (2) Months Course Length: Approximately 4 hours of study

time to complete this course This course addresses clinical trial management issues and skills needed to effectively conduct clinical trials. Key course factors include investigator selection and responsibilities, clinical research protocol, data management and adverse event reporting. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines. Educational Objectives Upon completion of this course, participants should be able to:

· Identify the sponsor's responsibilities in a clinical trial. · Discuss key considerations when selecting a Principal Investigator. · Describe the key elements for protocol development. · Discuss issues central to data management in a clinical trial. · Identify actions that must be taken when an adverse event is reported. · Explain the FDA inspection process and identify areas of common deficiencies.

Who Should Attend

· Study site investigators · Site monitors and auditors · Research nurses · Regulatory affairs associates · Data management personnel

Key Topics

· Sponsor Obligations · Protocol Development and Content · Data Management · Adverse Event Reporting · Investigator Responsibilities

This is the second course in the Good Clinical Practices for the Clinical Research Team Series. Series Description This course provides a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site- based investigator rather than the sponsor. This course provides an excellent tool for the training and education of all members of the sponsor and clinical research teams to insure their knowledge and understanding of the clinical research process and GCPs. Save when you bundle programs in series - all 3 courses for only $590!

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Ensuring Subject Protection & Scientific Integrity Course Rate: $160 Access Length: Two (2) Months Course Length: Approximately 2 hours of study

time to complete this course This course explains the FDA inspection process, identifies common deficiencies and regulations guiding FDA inspections and identifies the sponsor’s responsibilities in monitoring study sites. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines. Educational Objectives Upon completion of this course, participants should be able to:

· Identify the Sponsor's responsibilities for monitoring study sites. · Explain the FDA inspection process and identify areas of common deficiencies.

Who Should Attend

· Study site investigators · Site monitors and auditors · Research nurses · Regulatory affairs associates · Data management personnel

Key Topics

· Monitoring of Clinical Studies · Clinical Quality Assurance (CQA) · FDA Inspections

This is the third course in the Good Clinical Practices for the Clinical Research Team Series. Series Description This course provides a review of the clinical trial process. This course is different from many other courses in that its perspective is from that of the site- based investigator rather than the sponsor. This course provides an excellent tool for the training and education of all members of the sponsor and clinical research teams to insure their knowledge and understanding of the clinical research process and GCPs. Save when you bundle programs in series - all 3 courses for only $590!

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Pharmacology Online Course Rate: $615 Access Length: Four (4) Months Course Length: Approximately 15 hours of study time to complete this course This course provides an intensive overview of pharmacology, knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented, followed by an introduction to the pharmacology of the autonomic nervous system, cardiovascular system, and central nervous system. Inflammation and anti-inflammatory drugs are next presented, and the course concludes with a discussion of agents used in infectious disease and chemotherapy. Educational Objectives Upon completion of this course, participants should be able to:

· Describe the general principles of pharmacology. · Interpret the interrelationships between pharmacodynamics and pharmacokinetics. · Discuss the effects of drugs on the sympathetic and parasympathetic elements of the

autonomic nervous system. · Relate pharmacology as it applies to the major organ systems, central nervous system, and

cardiovascular system. Who Should Attend

· Project managers · Clinical research associates · Medical writers · Regulatory affairs specialists · Marketing professionals

Key Topics

· Principles of Pharmacodynamics · Introductory Pharmacokinetics · System Review I: Autonomic Nervous System

Pharmacology · System Review II: Cardiovascular System

Pharmacology · System Review III: Central Nervous System

Pharmacology

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Statistical Concepts Used in Clinical Trials Course Rate: $645 Access Length: Four (4) Months Course Length: Approximately 12 hours of study time to complete this course This course will review statistical terminology, provide an understanding of statistics, and explain trial design from a clinician's viewpoint. Most importantly, the course will illustrate how statistical tests are chosen and interpreted. The course is designed to allow you to think like a statistician, but it is not designed to teach you to be a statistician. The course will emphasize the importance of an ongoing collaboration with a statistician. It is this collaboration that creates synergy, enhances creativity, and improves trial design, execution, and analysis. Educational Objectives Upon completion of this course, participants should be able to:

· Identify patient populations and calculate the appropriate sample size for clinical trials. · Choose the trial endpoint and treatment difference to be detected. · Select statistical tests. · Interpret P-Values and determine statistical significance. · Determine the probability of detecting the drug effect.

Who Should Attend

· Physicians · Clinical research administrators · Clinical trial associates

Key Topics

· Introduction to Statistical Concepts in Trial Design · Patient Population · Control Treatment · Is the Experimental Treatment Better? · P-Values and Statistical Significance · Calculating the Sample Size of a Trial · Choice of a Statistical Test

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ARCHIVED WEBINARS

On-Demand Sessions on Featured Topics in Biopharmaceutical Development Did you ever have a meeting scheduled at the same time as the middle session in a webinar series? Had to stay home from work when an interesting webinar was held? Archived copies of many of PERI’s webinars are available for purchase. These 60- to 75-minute sessions can be accessed on-demand, whenever you need a refresher, an overview to a new topic, or clarification on specific diseases or regulations. Courses Available in the Following Fields:

· Basic Research Courses · Oncology · Pulmonary Drug Development · Global Clinical Trials · Labeling · Product Development & Launch · Emerging Topics in Drug Development Preview sessions online first!

Course Rate: $259/connection Access Length: 30 days Course Length: Three (3) 90-minute webinars

This three-part webinar series addresses the fundamentals of Project Management as it applies to the research-based biopharmaceutical industry.

Project Plans: Roadmaps to Project Success: Session 1 Project plans are created to address the project’s time, cost and resources adequately to estimate the work needed and to effectively manage risk during project execution. Project Teams: Vehicles Along the Road to Project Success: Session 2 Most biopharmaceutical projects involve multi-functional teams. Often times, the team members are geographically dispersed. Building an effective team, developing the team’s ‘personality’ and negotiating the complex social relationships in team settings is critical to project success. Project Communication: Mission Control: Session 3 Project teams encounter challenges when there are differences in expectations, surprises, lack of clarity regarding the status of the project, and last-minute requirements related to the project. Communication and stakeholder management are key in the success of multi-disciplinary teams that are typical for the biopharmaceutical industry.

PROJECT MANAGEMENT WEBINAR SERIES

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· · Registrations will not be processed without full payment. · You may register by mail, phone, fax, email, or through PERI’s

secure website. · Submit your registration form with full payment in order to hold

your place in a program. Registration fees are listed on the individual course pages of the website.

· We accept Visa, MasterCard, and American Express. You may also pay by bank or company check. We regret we cannot accept personal checks. To pay by check, please make checks in US dollars payable to PERI, Inc.

· If paying by check, PERI will hold your registration form until a check is received. Payment must be received at least three weeks prior to the start of the course in order for your registration to be processed. Please fax a copy of your check request form. Check requests will not be accepted within three weeks of the start of the course.

· Substitution: PERI will accept a registration substitution at any time prior to the start of the program. Please fax your substitution request to 571-490-8408.

· No-Shows: Registrants who are enrolled in a course and do not attend the program (“no-show,”) will not receive a refund.

· Program Discounts: Course discounts are available for employees from government and academic institutions, full-time college students, and groups of 3 or more. Corporate licensing is available for web-based programs. Contact the PERI office for details.

· Waiting List: Registrants on a waiting list who cancel or do not get into a course are not subject to cancellation fees.

OPEN ENROLLMENT COURSES

· Cancellations: Refund requests will be honored, less a cancellation fee, if written notice is received by PERI according to the following schedule: 30 days or more prior to first day of course – cancellation fee is 10% of registration fee; 29 to 10 days prior to first day of course – cancellation fee is 25% of registration fee; 9 days or less prior to first day of course – cancellation fee is 100% of registration fee.

· Cancellations: If PERI must cancel a course due to weather conditions or for any other reason, PERI will issue a full refund of the registration fees paid. In the event PERI cancels a course, PERI will refund the cancel/change fee for entire airline ticket but will not process refunds for hotel rooms.

· Transfers: Transferring to another course many be done if written notice is received by PERI at least 10 days prior to the start of the program. Transfers will notbe honored after this date. If the fee for the replacement course is more than what is available to transfer, you will be responsible for paying the difference and your registration will not be confirmed until we receive payment. The balance is due within 30 daysfrom the transfer date or the beginning date of the replacement course, whichever is earlier, or your registration will be forfeited. Transfers will be honored for one year from the date of the original course. After one year, your registration fee will be forfeited.

· Hotel Reservations: Participants are responsible for making hotel reservations. Participants are advised to make refundable or cancelable hotel reservations; PERI will not reimburse for non-refundable hotel reservations in the event of a course cancellation or reschedule.

LIVE WEBINARS

· Cancellation: Refunds will be honored (less a $50.00 processing fee) If written notice is received by PERI at least five business days prior to the start of the program. Refunds will not be honored after this date.

· If PERI must cancel a course due to technical difficulties, weather conditions or for any other reason, PERI will issue a full refund of registration fees paid.

DISTANCE EDUCATION COURSES

· Cancellation: Refunds will be honored (less a $100.00 enrollment fee) if written notice is received by PERI before accessing the course. Once you have accessed the course for any amountof time, cancellations and transfers will not be issued.

· Extensions: If you are not able to complete the distance education course in the time allotted, you may request an extension.Requests for an extension must be made in writing, and therewill be a fee of $100.00 for every 30 days of extended access.

BLENDED EDUCATION COURSES

· Definition: PERI offers some courses in a blended format, that is, the course may contain live and distance learning components (i.e., on-line courses and/or webinars). The course fee covers both the open enrollment and distance learning components for a single registrant; students cannot elect to register for only one component of the course. Registration cannot be split between students.

· Terms and Conditions: Upon registering for a blended course, the student will be given information on how to access the distance education component of the course. Students will have the specific access period for each course to complete the distance education component. This time period begins when a student registers for a blended course. Students may request an extension in writing no later than 30 days after the last day of the open enrollment course, and a fee of $100.00 for every 30 days of extended access is required.

· Cancellation: All cancellation and transfer request must be in writing, via fax 571-490-8408, attention: Registrar or email registrar@peri.org. Substitutions or transfers to another course are allowed if no component of the blended education course has been accessed. If the on-line course or webinar has been accessed by the student for ANY length of time, the price of the distance education component as a stand-alone course will be assessed. A fee based on the open enrollment cancellation schedule will be charged on the remaining registration balance. If the distance education course is not completed within 30 days, the last day of the open enrollment component, no refund for any portion of the on-line course or webinar will be provided unless an extension is requested and the extension fee paid.

REGISTRATION POLICIES

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PPaayymmeenntt MMeetthhooddCChheecckk eenncclloosseedd.. Please make checks in U.S. dollars payable to PERI, Inc. We regret we cannot accept personal checks.

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