MEDICAL AFFAIRS FOUNDATION eLearning Training Program
Gain the essential foundational knowledge for a successful career in Medical Affairs!
WHY ENROLL IN THE MEDICAL AFFAIRS FOUNDATION TRAINING PROGRAM?
This unique eLearning program provides anyone working in Medical Affairs with the extensive, foundational knowledge they need to be more effective in their role!
Who is this program for?
This program is ideal for anyone focused on a career in Medical Affairs including:
Medical Science Liaisons
Medical Science Liaison Leaders
Medical Information Professionals
Other roles in Medical Affairs
Aspiring Medical Science Liaisons
Aspiring Medical Affairs Professionals
WHAT’S IN THE PROGRAM?
All the eLearning courses include assessment questions throughout each course as well as a final assessment at the end. The entire program contains 40+ hours of virtual training which covers the essential knowledge needed to be successful working in Medical Affairs.
eLearning Courses Overview
1. Overview of the Pharmaceutical Industry
This course is designed to introduce you to the pharmaceutical industry. It begins with a brief history of the 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 course, 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 course 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 course 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 course, 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 course focuses on the processes whereby medicines are created, tested, manufactured, and brought to market. After completing this course, 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 course is designed to introduce you to the pharmaceutical drug discovery processes, and the ways in which they are influenced by biotechnology, regulatory bodies and their standards, and 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 course, 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. Pharmaceutical Research and Development
This course focuses on the Pharmaceutical Research & Development process. Throughout this course, you will learn about the pharmaceutical industry, the drug discovery and development processes, and challenges surrounding research and development in the industry. The course 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 course, 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 course introduces you to clinical trials, which is the principal means whereby pharmaceutical companies and medical researchers demonstrate the safety and efficacy of medicines. After completing this course, 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 (GCP)
- Outline the roles of the sponsor’s staff and investigational site personnel
- Discuss data analysis, reporting, and interpretation of results
7. Medical Terminology
This course is designed to give you a background on the origins of medical terminology. This is crucial for effective communication with KOLs and other healthcare providers. After completing this course, 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. The MSL Role and Activity Guidelines
This course covers the guidelines for the typical activities of Medical Science Liaisons and contains information generally applicable globally, based on the global “MSL Activity Guidelines” published by the Medical Science Liaison Society. The purpose of this course 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 course should not be viewed as a code, or rules, or laws; nor does this course or the guidelines document supersede local laws and regulations, regional codes, or individual company codes of conduct. Although this course is intended to be applicable globally, not all the guidance will apply to the laws of every country. After completing this course, 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 an MSL supports
9. Defining a Drug and Its Classification
This course provides an introduction to the classification of drugs including their function, composition, and characteristics as well as the implications of those characteristics for sales, marketing, and promotion. After completing this course, 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
- Describe various ways in which drugs are characterized
- Outline implications of drug characteristics for sales, marketing, and promotion
This course 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 regarding 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 course, you will be able to:
- Define pharmacokinetics
- Understand 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
- Understand the mechanisms and measurement of drug excretion
This course introduces you to Pharmacodynamics, which focuses on the physiological, biochemical, and molecular mechanisms of drugs. Once a drug enters the body, it creates a profound impact on physiology which allows it to act on its molecular or chemical targets through a cascade of complex events. Thus, together with the previous course, pharmacokinetics, this section gives you a better understanding of the details of a drug’s physiological effects. After completing this course, 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 course provides an introduction to the Prescribing Information, also known as package insert, drug labeling, drug product insert, professional labeling, the label, or simply PI. Although medical devices also have labels, the focus of this course is on the Prescribing Information for prescription drugs. After completing this course, 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 course provides an overview of the Medical Device industry, which develops and manufactures a vast range of non-medicinal products used in the treatment and diagnosis of illness. This course defines medical devices and provides an outline on how medical devices are regulated as well as describes the commercial characteristics of the industry. After completing this course, 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
- Describe the influence of healthcare professionals on product design and usage
14. Overview of Medical Affairs
This course 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 course, 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 (HEOR)
- 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
- Describe Medical Information activities
15. Introduction to Hospital Systems
This course provides an introduction to hospital systems. In this course, you will learn about the different types of hospitals and about the services they provide. The course also covers the administrative structure of a hospital. After completing this course, you will be able to:
- Differentiate between the different types of hospitals
- Describe the function of various hospital committees
- Describe the management of the hospital supply chain
- Outline the administrative structure of a hospital
16. Overview of Regulatory Affairs
This course 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 course, 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
- 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 was developed in collaboration with multiple current
MSL leaders, MSLs, and other Medical Affairs leaders
Cherie Hyder, PharmD, MSL-BC
Syndicated National MSL Director
Linda Traylor, PhD, MSL-BC
Sr. Director, Head Global
MSL Excellence – Oncology
Arthur Chan, PhD, MBA
of Medical Affairs
Josh Yoder, PhD, MSL-BC
Western US and Canada
Avery Ince, MD, PhD
Vice President, Medical Affairs – Cardiovascular & Metabolism
Ellen Shannon, PhD, RN, MSL-BC
US Head of Medical Affairs
Jihad (JR) Rizkallah, MD, MSL-BC
Director, Team Lead,
MSL Neurology West
Douglas Yau, PhD, MBA, CMD
Sr. Director Oncology,
US Field Medical Aairs
Head of Field Medical,
Oncology and Hematology
Rita Zambelas, MSN, MSL-BC
Tiama Chaar, PhD, MSL-BC
Medical Science Liaison Director – Oncology
Larry Dollar, PharmD, MS, MSL-BC
Victor Sastre, MSL-BC
Head of MSL Bone and
Bernadett Mamone, PhD
Medical Science Liaison
Christiane Carney, PhD
National Field Director, Medical Affairs
Elizabeth Kupferer, PhD, WHNP-BC
Participants will benefit from the multiple current MSL Leaders, MSLs, and Medical Affairs trainers who contributed content and collaborated on the development of this program.
Participants will gain a thorough understanding of the various laws, industry guidelines, and regulations impacting those working in Medical Affairs as well as broadly the pharmaceutical and medical device industries.
Eliminate the need to create comprehensive training programs from scratch or constantly update materials.
Easily ensure training has been fully completed and is clearly documented.
Reduce the amount of time managers, trainers, or mentors need to dedicate to training/onboarding, enabling them to focus on their core responsibilities.
Reduce the time required to fully train Medical Affairs employees with foundational knowledge by utilizing readily accessible and convenient comprehensive eLearning courses.
A single cogent training program for anyone working in Medical Affairs.
This program is fully accredited by IACET, adhering to international standards of excellence to ensure the knowledge gained throughout each course is the highest quality and has been externally validated.
What some Medical Affairs Leaders say about
the Medical Affairs Foundation Training Program
Jihad (JR) Rizkallah, MD, MSL-BC
Director, Team Lead, MSL Neurology West
The Medical Affairs Foundation Training Program that the MSL Society provides is an online comprehensive review of everything an MSL needs to know. The content applies to aspiring MSLs, current MSLs and managers as well. Having participated in the pilot program and take a handful of the courses, I highly recommend this online program to MSLs and leaders. It will definitely enhance your knowledge, skills and business acumen.
Douglas Yau, PhD, MBA, CMD
St. Director, Oncology, Medical Affairs
I had reviewed the Introduction to Hospital Systems and Drug Development elearning courses and can say that they were expertly developed.
Both of these courses would be a great modules for new MSLs who have not worked in the pharma industry or hospital system. It would provide them with a foundational working knowledge that typically is not covered in basic new hire therapeutic and disease state training. The Introduction to Hospital Systems course gave an excellent overview of the types of hospital systems that an MSL would work with. The Drug Development course provided the MSL learning with a working understand of the drug development process from preclinical to Phase IV.
Rita Zambelas, MSN, MSL-BC
Sr. Director, Medical Affairs
It was extremely informative and provided very clear concise definitions and examples in each section. I am very impressed by the accurate and concise content presented in a logical and systematic way to ensure understanding and rationale as well as regulatory and compliance requirements in place to ensure appropriate guardrails. Well done!
Frequently Asked Questions
Is the content applicable for Medical Affairs professionals working outside the U.S.?
I am not from the U.S., will I still be able to purchase and access all the courses?
YES. After completing the purchase, you will be able to access all 16 courses anywhere in the world.
Can I proceed to another course without completing the current one I am in?
Do you offer licenses for entire teams?
YES. Reach out to firstname.lastname@example.org for more information.
Can the courses be accessed offline?
What payment methods do you accept?
We accept payments online; VISA, Mastercard, or Paypal.
Are there downloadable files/PDFs/worksheets included with this eLearning program?
Do I need to complete the courses in a certain order?
Can I buy individual courses (as opposed to the entire 16 course program)?
Currently, we only offer the entire 16 course program or customized packages with multiple courses. However, we will be offering access to individual courses soon. Subscribe to our email list for updates!
Do you offer customized packages where I can select specific courses?
I have other questions not listed in the FAQ. Who should I contact?
You can reach out to Heliana Sula at email@example.com for any additional questions.