Course OVERVIEW
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© 2019 Medical Affairs Professional Society.All Rights Reserved
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: June 9, 2020
- Application Period Closes: August 1, 2020
- Application Decisions Emailed by: August 25, 2020
- Tuition Due Date: September 15, 2020
- Cohort Begins: October 12, 2020
- Cohort Concludes: December 18, 2020
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: Fundamentals of Clinical Pharmacology
Faculty: Anthony Fox
Title: Faculty of Life Sciences & Medicine at King´s College London, UK
Lesson 4: Applying Principles of Health Economics
Faculty: John Alter
Title: Vice President, Patient and Health Impact Lead Hospital Business Unit
Company: Pfizer, USA
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: Global Head of Medical Capability Development
Company: Sanofi, France
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: How to Assess a Clinical Research Paper
Faculty: Alan Boyd
Title: Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians, UK
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