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Comprehensive Medical Affairs Foundation eLearning Training Program

Enroll to learn the essential foundational knowledge needed to be more efficient and successful in your role as an MSL or Medical Affairs professional!

WHY MEDICAL AFFAIRS FOUNDATION CERTIFICATE TRAINING PROGRAM?


This unique eLearning program provides anyone in Medical Affairs with the extensive, foundational knowledge they need to be more effective in their role, ensuring they know how to add immediate value in their communication with KOLs.

What's Included

Who is this program for?

This program is ideal for anyone in medical affairs looking to ensure you have the foundational training necessary to succeed in a company.

Medical Science Liaisons

Medical Science Liaison Leaders

Anyone working in Medical Affairs

Aspiring Medical Science Liaisons

Aspiring Medical Affairs Professionals

Virtual training details

Each eLearning course includes assessment questions throughout the course and a final assessment at the end. This 35 + hours virtual training covers the essentials any medical affairs professionals need to succeed at any company.

eLearning Courses Overview

1. Overview of the Pharmaceutical Industry

This learning program is designed to introduce you to the pharmaceutical industry. The program begins with a brief history of the pharmaceutical industry, describes the process of research and development, and covers global industry statistics. You will also learn about the various types of pharmaceutical and biotechnology companies, and about the challenges facing pharmaceutical companies today. The pharmaceutical industry is currently influenced by biotechnology, regulatory standards, and the pharmaceutical market. In order to understand the competition and alliances that form in the industry, it is important to grasp the complexity and intensity of the search for new drugs and their development. After completing this program, you will be able to:

  • Define and describe the pharmaceutical industry
  • Summarize the steps involved in drug discovery and development
  • Outline the challenges facing the pharmaceutical industry
2. Understanding Clinical Reprints

This learning program introduces you to clinical reprints of articles that are based on clinical trials, and which are published in medical journals. First, it will discuss the purpose of clinical reprints, as well as the reporting and publication process. This program then reviews each section of a clinical reprint, explaining the typical content included in each section and defining commonly used terms. Clinical reprints help KOLs and other HCPs make informed decisions about patient care, and it is therefore crucial for an MSL to present the clinical trial results to KOLs in a way that enables them to make informed decisions about potential new drugs or treatment options. After completing this program, you will be able to:

  • Discuss issues related to clinical trial reporting and publication
  • List the purposes and typical content of a clinical reprint’s Title, list of Authors, Abstract, and Introduction section
  • Discuss important aspects of study population and study design that are presented in the Methods section of a clinical reprint
  • Define primary and secondary study endpoints
  • Discuss statistical analyses used to evaluate study endpoints
  • Describe the types of efficacy and safety findings typically presented in the Results section of a clinical reprint
  • List the purposes and typical content of the Discussion and Conclusion sections of a clinical reprint
3. Drug Development

This learning program focuses on the processes whereby medicines are created, tested, manufactured, and brought to market. As an essential figure in the industry, you must be knowledgeable in the fine details surrounding the beginning stages of developing drugs. After completing this program, you will be able to:

  • Identify the main approaches to drug discovery
  • Explain the role of preclinical studies in drug development and describe procedures involved
  • Outline the role of clinical trials in drug development
  • Discuss challenges, strategy and trends in drug development
4. Drug Discovery
This learning program is designed to introduce you to the pharmaceutical drug discovery and development processes, and the ways in which they are influenced by biotechnology, regulatory bodies and their standards, pharmaceutical market conditions, all of which are important and specific to the modern era. In order to understand the competition and alliances that form in the market, it is important to grasp the complexity and intensity of the search for new drugs and their development. After completing this program, you will be able to:

  • Define a drug and describe five possible drug functions
  • Understand the differences between a small molecule and large molecule drug
  • Explain eight processes used in drug discovery
  • Describe the role of biotechnology in the pharmaceutical industry
5. R&D
This learning program focuses on the Pharmaceutical Research & Development process. Throughout this program, you will learn about the pharmaceutical industry, the drug discovery and development processes, and challenges surrounding research and development in the industry. The program begins with an overview of the organization and management of research and development (R&D) and continues with an in-depth look at the issue of competition among pharmaceutical companies. You will also learn about the various external interactions that pharmaceutical companies have with other organizations and individuals. After completing this program, you will be able to:

  • Summarize important organization and management issues involved in R&D
  • Explain the types of competition among pharmaceutical companies and its effects
  • Understand the government regulations that guide drug discovery and development
  • Describe the internal and external interactions that are important to pharmaceutical companies
6. Clinical Trials
This learning program introduces you to clinical trials, which is the principal means whereby pharmaceutical companies and medical researchers demonstrate the safety and efficacy of medicines.  It is essential to be well-versed in this facet of the MSL profession, as clinical trials catalyze scientific breakthroughs which improve the overall healthcare system. After completing this program, you will be able to:

  • Describe the purpose of clinical trials
  • Discuss the criteria for selection of subjects
  • Specify major parameters of trials, such as phase, endpoints, and controls
  • Describe means of eliminating bias
  • Describe the design of clinical trials
  • Identify documentation required for a trial
  • Apply for authorization to conduct clinical trials
  • Understand the importance of Good Clinical Practice
  • Outline the roles of the sponsor’s staff and investigational site personnel; and
  • Discuss data analysis and the reporting and interpretation of results
7. Medical Terminology
This learning program is designed to give you a background on the origins of medical terminology. You will also be able to deconstruct a medical term into its individual parts and describe what these parts are, which is crucial for effective communication with KOLs and other healthcare providers. After completing this program, you will be able to:

  • Describe the origins of medical terminology
  • List the 3 main word elements used in medical terminology
  • Identify anatomy terms and their key elements
  • Identify location and direction terms
  • Identify pathology terms and their key elements
  • Identify diagnosis terms and their key elements
  • Identify therapy terms and their key elements
8. MSL Role and Activity Guidelines
This learning program covers the guidelines for the typical activities of Medical Science Liaisons and it contains information generally applicable globally. It is based on the global “MSL Activity Guidelines” produced by the Medical Science Liaison Society. The purpose of this program and the guidelines it’s based upon, is to serve as a comprehensive reference and provide recommendations related to the appropriate internal and external activities of MSLs. However, this program should not be viewed as a code, or rules, or laws; nor does this program or the guidelines document supersede local laws and regulations, regional codes, or individual company codes of conduct. Although this program is intended to be applicable globally, not all the guidance will apply to the laws of every country. After completing this program, you should be able to:

  • Articulate the operations and activities of Medical Science Liaisons
  • Know the typical activities and responsibilities of MSLs and the established standards of the profession
  • Foster ethical relationships with KOLs
  • Facilitate the exchange of valid, unbiased, fair, and balanced scientific information within the context of a medical product or device and the therapeutic area that the MSL supports.
9. What is a Drug? (Defining a Drug and Its Classification)
This learning program aims to introduce you in detail to drugs – their function, composition, and characteristics, and the implications of those characteristics for sales, marketing, and promotion. After completing this program, you will be able to:

  • Define what a ‘drug’ is
  • Outline mechanisms of action
  • Describe components of a drug product
  • Specify routes of administration and their effects on bioavailability
  • Identify studies of the interaction of drug and body
  • Describe various ways in which drugs are characterized
  • Outline implications of drug characteristics for sales, marketing, and promotion
10. Pharmacokinetics
This learning program is designed to introduce you to Pharmacokinetics, which studies the time and course of drug absorption, metabolism, distribution, and excretion.  It answers some of the most important questions revolving around drugs, such as what happens once they are administered, once they move throughout the body, and the duration before they are eliminated from the body. After completing this program, you will be able to:

  • Define pharmacokinetics
  • Recall the basic concepts in pharmacokinetics
  • Identify the key factors underlying the process of drug absorption
  • Describe the factors affecting distribution of drugs in the body
  • Identify the mechanisms and consequences of drug metabolism
  • Recall the mechanisms and measurement of drug excretion
11. Pharmacodynamics
This learning program introduces you to Pharmacodynamics, which focuses on the physiological, biochemical, and molecular mechanisms of drugs.  Once a drug enters our body, it creates a profound impact on our physiology to allow it to act on its molecular or chemical targets through a cascade of complex events.  Thus, together with the previous program, pharmacokinetics, this section gives you a better understanding of the details of a drug’s physiological effects. After completing this program, you will be able to:

  • List the major types of drug receptors
  • Identify the types of effects drugs can exert on receptors
  • Recall the measurements used to quantify the dose-response relationship
  • Understand the measurements used to quantify drug affinity
  • Define the therapeutic window and therapeutic index
  • Identify the pharmacodynamic factors that can introduce variability to drug response
12. Prescribing Information (PI)

This learning program aims to introduce you to the Prescribing Information, also known as package insert, drug labeling, drug product insert, professional labeling, the label or simply PI. It provides detailed drug information assembled by the drug manufacturer,  which is distributed by a particular company after review and approval by a regulatory authority (for example, the FDA in the U.S.). Although medical devices also have labels, the focus of this program is on the Prescribing Information for prescription drugs.

After completing this program, you will be able to:

  • Explain the purpose of the Prescribing Information
  • Identify various ways in which information on medicines is provided to healthcare providers and patients
  • Outline the required sections of the Prescribing Information in the U.S.
  • Describe important contents of the Prescribing Information in the U.S.
  • Outline the sections of the summary of product characteristics in Europe
  • Discuss international differences in drug labeling
  • Understand how to access prescribing information online
13. Overview of the Medical Device Industry

This learning program focuses on the Medical Device industry, which develops and manufactures a vast range of non-medicinal products used in the treatment and diagnosis of illness.  This particular course will first define medical devices and give examples, followed by an outline on how medical devices are regulated, and finally describe commercial characteristics of the industry.

After completing this program, you will be able to:

  • Define medical devices and give examples
  • Outline how medical devices are regulated, particularly in the U.S. and Europe
  • Describe commercial characteristics of the medical device industry, such as market dominance by a small number of large players, the much larger number of small players, the making of frequent incremental changes to product design, and the influence of healthcare professionals on product design and uptake
14. Overview of Medical Affairs

This learning program introduces you to Medical Affairs, an important entity within a pharmaceutical, biotechnology, medical device, or other healthcare company.  It is a department that focuses on communicating accurate information to other stakeholders in the healthcare industry, which include healthcare professionals and leaders.

After completing this program, you will be able to:

  • Summarize the role of Medical Affairs within a pharmaceutical, biotechnology, medical device, or other healthcare company
  • Outline the ways in which Medical Affairs benefits the company
  • Identify typical activities of Medical Affairs
  • Discuss the contributions of Medical Affairs to clinical research and development
  • Discuss the contributions of Medical Affairs to health economics and outcomes research
  • Describe medical education and training activities
  • Describe medical communications activities
  • Discuss the role of Medical Science Liaisons, especially the cultivation of relationships with Key Opinion Leaders; and
  • Describe Medical Information activities
15. Introduction to Hospital Systems

This learning program is designed to introduce you to the hospital system in the United States. In this program, you will learn about the different types of U.S. hospitals and about the services they provide. The program also covers the administrative structure of a hospital.

After completing this program, you will be able to:

  • Differentiate between the different types of hospitals in the U.S. system
  • Describe the function of various hospital committees
  • Describe the management of the hospital supply chain
  • And outline the administrative structure of a hospital
16. Overview of Regulatory Affairs

This learning program gives you an overview of the Regulatory Affairs industry, which revolves around overseeing drugs, medical products, and food from their development stages up to their distribution to ensure that they meet specific standards for human use and consumption.

After completing this program, you will be able to:

  • Define the regulatory affairs function, list responsibilities of regulatory affairs professionals, and outline the legal and regulatory framework within which the drug industry operates in the U.S. and the European Economic Area (EEA)
  • Describe possible consequences of non-compliance with regulations
  • Distinguish different categories of drugs
  • Recognize the characteristics of the drug discovery stage
  • Outline the main characteristics of the preclinical studies stage
  • Recognize the functions of the four phases of clinical development and be aware of the regulatory requirements that apply
  • Outline regulatory requirements from the onset of a drug’s development
  • Describe procedures for gaining and maintaining authorization to conduct clinical trials
  • Outline the principles of Good Clinical Practice (GCP)
  • Describe requirements on applications for marketing approval, and the procedures to be followed, in the U.S. and EEA
  • Define Orphan Drugs and identify incentives for their development
  • Specify naming conventions for a new medicinal product
  • Identify circumstances in which a new product may be used outside clinical trials before it receives marketing approval
  • Describe how to apply for a supplement to a New Drug Application (NDA) or Biologics License Application (BLA) in the U.S.
  • Explain what pharmacovigilance measures need to be taken and what would happen if these were not implemented
  • Outline the function and validity of patents and market exclusivity
  • Summarize key points about advertising drugs
  • Describe how to apply for a variation to a marketing authorization in the EEA

Meet Some of the many 
Medical Affairs Leaders 
who contributed to the content

The eLearning program is developed in collaboration with multiple current MSL managers and medical affairs leaders.

Samuel Dyer, PhD

CEO and Chairman

 

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Cherie Hyder, PharmD, MSL-BC

Syndicated National MSL Director

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Linda Traylor, PhD, MSL-BC

Senior Principal,
Medical Affairs

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Ralph Rewers

Sr. Director,
Head Global MSL Excellence

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Arthur Chan, PhD, MBA

Vice President
of Medical
Affairs

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Avery Ince, MD, PhD

Vice President, Medical Affairs – Cardiovascular & Metabolism

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Ellen Shannon, PhD, RN, MSL-BC

US Head of Medical Affairs

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Jihad (JR) Rizkallah, MD, MSL-BC

Director, Team Lead,
MSL Neurology West

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Douglas Yau, PhD, MBA, CMD

Sr. Director Oncology,
US Field Medical Aairs

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Paul Ward

Head of Field Medical,
Oncology and Hematology

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Rita Zambelas, MSN, MSL-BC

Sr. Director,
Medical Affairs

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Tiama Chaar, PhD, MSL-BC 

Senior Medical
Science Liaison

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Larry Dollar, PharmD, MS, MSL-BC

Vice President,
Medical Affairs

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Victor Sastre, MSL-BC

Head of MSL Bone and
Inflammation

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Bernadett Mamone, PhD

Senior MSL

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Christiane Carney, PhD

Senior Medical
MSL Regional Leader (East)

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Elizabeth Kupferer, PhD, WHNP-BC

National Director,
Women’s Health

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4

unique benefits
for MSL managers

4

unique benefits
for MSLs

Expedited Training for Teams
Proper foundational training reduces the amount of time that managers or mentors have to dedicate to training, freeing them to focus on their own responsibilities.

Fully Accredited Training
All MSL Society training programs are fully IACET-accredited and adhere to international training standards, ensuring the knowledge learned is of assured quality and value.

Save Company Resources
This comprehensive eLearning training program eliminates the need to create company training materials from scratch, or update them according to the latest developments

Gain Foundational Knowledge
The eLearning is designed to teach MSLs and Medical Affairs professionals the necessary foundational knowledge and skills needed to be more efficient in their roles.

Comprehensive Progress Tracking
As the team undergoes the same training program, MSL & Medical Affairs leaders are assured of consistent and comprehensive training which also gives them a clear system for tracking individual members’ progress. This consistency of training also lets them set clear expectations for the team.

Learn from Industry Experts
Multiple current MSL & Medical Affairs leaders and trainers from top companies have been involved in the development of this eLearning.

Consistent Training
MSLs & Medical Affairs professionals within the same company who will enroll in the program undergo the same essential training and learn the same foundational knowledge, skills, relevant laws, industry guidelines, and regulations concerning the profession thus allowing consistency.

Accelerate Professional Growth
TThe eLearning Training Program teaches MSLs and Medical Affairs professionals the essential foundational knowledge, making sure they know how to add immediate value to their stakeholders.

Pricing

Enroll now to add immediate value to stakeholders. Is your entire team enrolling? Reach out to Heliana Sula at heliana.sula@themsls.org to inquire about team discounts!


STUDENT*

* Student level membership required. Join Now!

$2700

$2500

ENROLL NOW


MSL SOCIETY MEMBER*

* Professional or Organization level member required.

$2900

$2800

ENROLL NOW


NON-MEMBER*

*This price includes a 1-year Professional level membership which will be activated upon purchase of the program

$3000

$2900

ENROLL NOW

Looking for onboarding training? The Medical Affairs Foundational Certificate Training Program is included in the MSL Onboarding Training Program. Learn more HERE.

Some of the MSL teams that we have trained

Sanofi-Genzyme
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Shionogi logo
(PRNewsfoto/Partner Therapeutics, Inc.)
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Shionogi logo
Shionogi logo
Shionogi logo
Shionogi logo
Shionogi logo
Shionogi logo
Shionogi logo
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Fresenius Kabi Company Logo
Marinus Pharmaceuticals Company Logo

What some Medical Affairs Leaders say about
the
Medical Affairs Foundation Training Program

Susan Payne, BSN, RN, CWCN

MSL, RTI Surgical
“Our MSL team recently attended a 2-day training program on Insights gathering in Sarasota Florida with Samuel Dyer and the MSL Society team. This training program was instrumental in creating team bonding, helped us create goals, and formulate a structured plan for gathering and sharing information with KOLs. This training helped our team further define our roles and functions as MSL’s within our company. This experience left us feeling confident and prepared, with valuable new skills for insight gathering in the field.”

Jennifer Stanke, PhD

Sr. Manager, Medical Science Liaison, Foundation Medicine
“Our team recently participated in 2 virtual Maximizing performance training sessions with Samuel Dyer and the Medical Science Liaison Society. Topics covered the recent shift in the MSL role, tactics for Virtual KOL Engagement as well as Medical Insights Gathering. The KOL Engagement session served as great training for the first-time MSLs on our team as well as a refresher for those with more experience. I personally found value in the Insights session where we learned how to best represent the voice of our customers to the decision-makers at the company. The skill of taking everyday feedback and placing that data in the proper context in order to drive change is an essential yet nuanced skill I would encourage MSLs at all levels to develop. I used this technique the very next day. The MSLS delivered detailed training and I highly value the content as well as the team building with my colleagues-many of which were onboarded during the pandemic.”

Lille Tidwell, PhD

Medical Science Liaison, ALK
“The training program conducted by the MSL Society was excellent! I enjoyed learning about the rationale behind the activity of gathering insights, from goals to strategy to tactics. As a member of a fairly new MSL team, this training facilitated our understanding of insights starting from the same page. I now have to tools to implement a better framework to gather insights consistently and in a more meaningful, actionable way for my company.”

Emily Frisch, MPA, RN, OCN

Field Medical Liaison, Partner Therapeutics
“I took part in three virtual training programs facilitated by Dr. Samuel Dyer with another colleague as we recently transitioned to an MSL role. I can’t speak highly enough of the quality of the MSL Society’s programs, the resources, and of Dr. Dyer’s skill as an educator. He has an ability to teach and share applicable resources, data and robust to experience in a highly relevant and tailored way. Moreover, the training is truly engaging and actually fun! The material I learned not only helped to facilitate my transition to my new MSL position, but it provided me with the platform in which to continue learning. The resources on the MSL Society website captures real-world and timely information and guidance that applies to this unique COVID era and readily translates into my outreach and interactions with providers. I have an entirely new vantage point on my outreach and have gained several perils of wisdom that are now integrating into my day-to-day role. Dr. Dyer and the MSL Society are truly top-notch and a significant value-add. I plan on continuing my training with their offerings and resources during my tenure as an MSL.”

Greg Grevera, DNP

Medical Science Liaison, Servier Pharmaceuticals
“Samuel and the team at Medical Science Liaison Society provided our MSLs with four beneficial virtual training sessions. Topics ranged from Virtual KOL Engagement to Insights Gathering. The sessions were practical and ready to implement from day one after the workshop. I’ve been in Medical Affairs for 20 years, and these courses and conversations enabled me to challenge what I know and look at various areas of the MSL role through a different lens.”

Mark Hali, MBA

Field Medical Liaison, Partner Therapeutics
“I attended 3 separate live virtual MSL training programs offered by the MSL Society which were all facilitated by Dr. Samuel Dyer. I was delighted by (1) the evidence-based approach to the material across all the programs, (2) Samuel’s passion for training and the materials, and (3) the organized way it was conducted. The programs really helped me embrace the content with confidence and allowed me to put aside any preconceived ideas that might have caused any doubt about applying the recommended approaches and techniques. I absolutely recommend attending training programs offered through the MSL Society to any MSL, new or tenured!”

Andrea Scherschel

Medical Science Liaison, Shionogi
“My team and I recently attended a virtual training program from Dr. Samuel Dyer, CEO of the MSL Society on Improving KOL interactions in a Virtual World. The training session was excellent! Dr. Dyer reviewed best practices that ranged from how to develop an executive presence to how to send a highly effective email that will catch your KOL’s attention. While a few of the suggestions were good reminders of techniques I have learned in the past (and forgotten), I also learned new ways of interacting. The session was practical and provided techniques that I have already begun to incorporate into my daily activity. I would highly recommend this training for all MSL teams. Thank you!”

Marc Giry-Laterriere, PhD

Marc Giry-Laterriere, PhD

Medical Science Liaison, CSL-Behring Australia
“Samuel provided a 3 day MSL training that was masterfully delivered and very well thought through. After 4 years in the job and a number of formal and informal trainings (including Samuel’s book and some of the MSL Society resources), the course still gave me the opportunity to revisit the fundamentals, become more aware of the areas where I need to improve and discuss strategies and techniques to do so. The scenarios and discussions with colleagues were very enriching. I would definitely recommend this course to any MSL who, like Samuel and I, think it’s one of the best jobs in the world!”

Mason Yeh, PhD

Medical Science Liaison, UCB Pharmaceuticals
“Samuel and Heliana delivered a tailored, informative 2-day training module for our MSL team, which is made up of individuals with diverse backgrounds and MSL experience. This said, Samuel’s presentations were impactful and data-driven, which resonated well with the team. Further, Samuel incorporated thought-provoking competency and soft-skills workshops that engaged the entire group. Thank you for the opportunity to learn and develop as an MSL, Samuel and Heliana!”

Frequently Asked Questions