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Transitioning into Medical Affairs?
Discover your place in the function and demonstrate your skills to potential employers
Take the Next Step in Your Career
Connect with peers while seeing a big picture of drug development that can help you move beyond your silo into a strategic role
Application Deadline
April 12, 2021
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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
KEY DATES
- Application Period Opens: February 15, 2021
- Application Period Closes: April 12, 2021
- Application Decisions Emailed by: April 14, 2021
- Tuition Due Date: April 19, 2021
- Cohort Begins: April 19, 2021
- Cohort Concludes: June 25, 2021
- Exam Option #1: June 28, 2021
- Exam Option #2: June 30, 2021
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
Faculty: Rozlin Schneider
Title: Vice President Scientific, Medical and Patient Affairs of Pharmaceutical Medicine
Company: Theravance Biopharma. USA
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
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
