Introduction to Medical Affairs in Medicines Development

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 expert leaders 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.

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.

The tuition fee for the course can be divided into two equal payments of $1,150 USD payable via credit card, debit card, or bank account via PayPal’s secure payment service. Payment due dates: September 14th and October 19th, 2020.

Key Dates

  • Application Period Opens: June 9, 2020
  • Application Period Closes: September 1, 2020
  • Application Decisions Emailed on rolling basis
  • Cohort Begins: September 7, 2020
  • Tuition Due Date: September 14, 2020
  • Cohort Concludes: December 4, 2020

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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 3: Fundamentals of Clinical Pharmacology

Faculty: Anthony Fox

Title: Former Faculty of Life Sciences & Medicine at King´s College London, UK



Lesson 5: Overall Regulations and Harmonization

Faculty: Xavier Luria

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



Lesson 7: Sustaining the Product Life Cycle

Faculty: Tamas Suto

Title: SVP and Head of Global Medical Affairs Oncology
Company: Merck Group, Germany



Lesson 9: Principles of Safety and Clinical Toxicology

Faculty: Xavier Luria

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


Lesson 2: The Purpose and Identity of Medical Affairs

Faculty: Pol Vandenbroucke

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



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 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 8: Field Medical/The MSL function

Faculty: Nikolas Karkanias

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



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 3: Emerging issues in Exploratory Development

Faculty: Sandor Kerpel-Fronius

Title: Professor at Semmelweis University Department of Pharmacology
and Pharmacotherapy Budapest, Hungary


Webinar 2: Biosimilars in Key Markets

Faculty: John Kelton & Mark Latymer

Titles: Medical Director Oncology Biosimilars & Senior Director Biosimilars Portfolio
Company: Pfizer, USA & UK



Webinar 4: Field Medical/MSL Strategy and practice

Faculty: Nikolas Karkanias

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