Introduction To Medical Affairs In Medicines Development

2021 Cohort

Course OVERVIEW

On behalf of MAPS and IFAPP Academy, we would like to introduce you to the Introduction to Medical Affairs in Medicines Development Course. This course was designed for the Medical Affairs professional who wants to further learn the fundamentals of Medicines Development and how the various Medical Affairs functions contribute to bringing better medicines to the marketplace, meeting the patient needs and improving health in the general population.

This course was adapted from the ongoing professional certification program the IFAPP Academy has developed with King’s College London. It gathers together experts from the pharmaceutical industry, regulatory agencies and academic institutions to offer the latest advances in all areas of Medicines Development as well as tips for the effective practice of the Medical Affairs function through state-of-the art interactive distance learning.

Hear what IFAPP and MAPS Leadership have to say about this course:

Course format

To earn the Introduction to Medical Affairs in Medicines Development certificate of completion, a student must complete and pass the course, completing 10 Lessons + 4 Webinars + the Final Assessment. A student will need to be self-directed, self-motivated, and well-organized in their studies and in completing the course work.

Each lesson typically requires 3-5 hours each week.

One Lesson per Week for 10 Weeks

3 – 5 hours per week

Online Lecture
Post Lecture Quiz
Student Lounge Q&A

Webinars (total of four)

1.5 – 2.5 hours per webinar

One hour recorded webinar
Post webinar assignment

Final Assessment

1-hour exam + additional study time

30 multiple choice questions
Two opportunities available to pass examination

who should take this course

Ideally, to participate in the course, an individual should possess a post-graduate education in Biomedical Sciences – at least a BS degree or its equivalent – and at least one year of work experience in the Medical Affairs arena either in the biopharmaceutical or contract research organizations industry. Of course, there may be exceptional individuals who bring other criteria to the table and those applicants will be considered on a case-by-case basis. If you are relatively new to the profession, we encourage you to review the Course outline and consider utilizing this exceptional opportunity.

Tuition

Introduction to Medical Affairs in Medicines Development Course: $2,300.00 USD.

Payments can be made via credit card, debit card, or bank account via PayPal’s secure payment service.

KEY DATES

Application Period Opens: February 15, 2021
Application Period Closes: April 2, 2021
Application Decisions Emailed by: April 5, 2021
Tuition Due Date: April 9, 2021
Cohort Begins: April 12, 2021
Cohort Concludes: June 25, 2021
Exam Option #1: June 28, 2021
Exam Option #2: June 30, 2021

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Course syllabus

Lesson 1: Current Trends and Challenges in Pharmaceutical R&D

Faculty: Kenneth Kaitin

Title: Director Tufts Center for the Study of Drug Development
Professor Tufts University School of Medicine, USA

Lesson 2: The Purpose and Identity of Medical Affairs

Faculty: Pol Vandenbroucke
Title: Chief Medical Officer Hospital Business Unit
Company: Pfizer, USA

Lesson 3: Basics of Clinical Pharmacology (PK and PD)

Faculty: Sandor Kerpel-Fronius
Title: Professor at Semmelweis University Department of Pharmacology and Pharmacotherapy Budapest, Hungary

Lesson 4: Health Systems and Health Economics

Faculty: Laurent Pacheco
Title: Managing Director, Value Access & HEOR
Company: Syneos, UK

Lesson 5: Overall Regulations and Harmonization

Faculty: Xavier Luria
Title: Chair and Senior Consultant
Company: Drug development and Regulation, Spain

Lesson 6: The Discovery Process and Non-Clinical Development

Faculty: Sandor Kerpel-Fronius
Title: Professor at Semmelweis University Department of Pharmacology and Pharmacotherapy Budapest, Hungary

Lesson 7: Sustaining the Product Life Cycle

Faculty: Tamas Suto
Title: SVP, Global Head of Oncology Medical Affairs, Merck EMD Serono
Company: Merck EMD Serono, Germany

Lesson 8 The MSL function

Faculty: Nikolas Karkanias
Title: Senior Director Global Digital Partner Hospital and Rare Diseases Business Unit
Company: Pfizer, USA

Lesson 9: Principles of safety and clinical toxicology

Faculty: Xavier Luria
Title: Chair and Senior Consultant
Company: Drug development and Regulation. Spain

Lesson 10: Patient Centered Medicines Development by Rozlin Schneider

Faculty: Rozlin Schneider

Title: Vice President Scientific, Medical and Patient Affairs of Pharmaceutical Medicine

Company: Theravance Biopharma. USA

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WEBINARS

Webinar 1: Ongoing issues in Medicines Development

Faculty: Kenneth Kaitin
Title: Director Tufts Center for the Study of Drug Development
Professor Tufts University School of Medicine, USA

Webinar 2: Biosimilars in Key Markets

Faculty: John Kelton
Title: Medical Director Oncology Biosimilars
Company: Pfizer, USA

Faculty: Mark Lathymer
Title: Senior Director Biosimilars Portfolio
Company: Pfizer, UK

Webinar 3: Emerging issues in Exploratory Development

Faculty: Sandor Kerpel-Fronius
Title: Professor at Semmelweis University Department of Pharmacology and Pharmacotherapy Budapest, Hungary

Webinar 4: MSL Strategy and practice

Faculty: Nikolas Karkanias
Title: Senior Director Global Digital Partner Hospital and Rare Diseases Business Unit
Company: Pfizer, USA

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