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 ENROLL IN THE MEDICAL AFFAIRS FOUNDATION 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.
Who is this program for?
this course 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
WHAT’S IN THE PROGRAM?
Each eLearning course includes assessment questions throughout the course and a final assessment at the end. This 40 + 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 course is designed to introduce you to the pharmaceutical industry. The course 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 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. 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 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 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 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. 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 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
- 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 course 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 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 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 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 the MSL supports
9. Defining a Drug and Its Classification
This course 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 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
- 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 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 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 course, 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 course 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 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 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 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 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 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, 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 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
- 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 course is designed to introduce you to the hospital system. 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
- And 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
- 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.
Cherie Hyder, PharmD, MSL-BC
Syndicated National MSL Director
Linda Traylor, PhD, MSL-BC
Senior Principal,
Medical Affairs
Ralph Rewers
Sr. Director,
Head Global MSL Excellence
Arthur Chan, PhD, MBA
Vice President
of Medical Affairs
Josh Yoder, PhD, MSL-BC
Regional Director
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
Paul Ward
Head of Field Medical,
Oncology and Hematology
Rita Zambelas, MSN, MSL-BC
Sr. Director,
Medical Affairs
Tiama Chaar, PhD, MSL-BC
Senior Medical
Science Liaison
Larry Dollar, PharmD, MS, MSL-BC
Vice President,
Medical Affairs
Victor Sastre, MSL-BC
Head of MSL Bone and
Inflammation
Bernadett Mamone, PhD
Senior MSL
Christiane Carney, PhD
Director
Field Medical Affairs
Elizabeth Kupferer, PhD, WHNP-BC
National Director,
Women’s Health
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!
NON-MEMBER*
*This price includes a 1-year Professional level membership which will be activated
upon purchase of the program
$3000
$2700
Looking for onboarding training? The Medical Affairs Foundational Certificate Training Program is included in the MSL Onboarding Training Program. Learn more HERE.
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
Sunovion Pharmaceuticals
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
Sanofi
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
4DMT
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 personnel outside the US, or is it only relevant to personnel in the US?
YES. The courses were designed for foundational knowledge on Medical Affairs applicable in pharmaceutical, biotechnology, medical devices, and other healthcare fields globally.
I am not from the US. Will I still be able to purchase and access this course?
YES. After purchase, you can access all 16 courses wherever you are in the world.
Can I proceed to the next course without passing the current one I am in?
YES. You can just return to courses you need more time with, or take on particular courses first regardless of their order in the program. However, you must complete all 16 courses before you can be awarded with the certificate
Do you offer licenses for entire teams?
YES. Reach out to heliana.sula@themsls.org for more information.
Can the courses be accessed offline?
NO. An internet connection is needed to log in and access the platform.
Will there be downloadable files/PDFs/worksheets that come with this eLearning course?
NO. All the courses and assessment checks are purely digital, so you can access all eLearning courses at the convenience of your gadgets.
Do I need to take the courses in a certain order?
NO. We designed this course in a way that you can decide on what order you would like to take the courses depending on your preferences or priority.
What payment methods do you accept?
We accept payments online; VISA, Mastercard, or Paypal.
Can I buy individual courses instead of buying the whole program?
As of the moment, you can purchase the program as a whole with all 16 courses included, but we are working to offer the individual courses soon. Check out this page, follow us on LinkedIn, or be part of our email list to receive updates!
I have other questions not listen in the FAQ. How do I get answers?
You may reach out to Heliana Sula at heliana.sula@themsls.org for any additional questions.
