Comprehensive MSL Onboarding Training Program

• Engaging with KOLs virtually
• Researching KOLs before a virtual engagement
• Creating value-based agendas
• Convincing KOLs to meet virtually
• Preparing for a virtual engagement
• During a virtual engagement
• After a virtual engagement
• Zoom fatigue

Learning Objectives:

• Document goals and strategies within the first year
• Maximize your activities and productivity
• Understand how to divide your activities into segments that target specific objectives
• Plan of action with timelines to achieve target tasks
• Set achievable goals that deliver and demonstrates value to your company
• Outline of specific learning goals and milestones
• Helps leadership understand your achievements
• Understand how to more effectively add value to your company AND KOLs

Learning Objectives:

• The difference between goals, strategy, and tactics
• Why understanding medical strategy drives insights gathering
• The definition of an insight
• Why insights are important
• Categories of insights
• The key components of actionable insights
• How to identify insights
• The difference between what a KOL said and an insight
• Best practices for communicating insights internally
• The key components of actionable insights
• How to compose actionable insights
• Challenges around analyzing and reporting insights

• Effective KOL Interactions
• How to add value to KOLs
• Communication Skills
• Insight Gathering Skills
• Making complex slides simpler to understand
• Dealing with difficult stakeholders more confidently
• Objection Handling Skills
• Building Long Term Relationships

• KOL Pre-Visit Planning
  • What does being prepared look like
  • How to prepare
  • Developing a strategy
  • Objection Handling Skills
• KOL Visit
  • How to approach
  • Difficult vs demanding KOLs
  • How to build credibility
  • The importance of Communication Skills
• KOL Post-Visit Planning
  • Model and tool on how to capture insights
  • Next Steps
  • Summary

Learning Objectives:

• Types of scientific literature
• Structure of scientific papers
• Clinical trial design
• Evaluating study results
• Assessing the value of a scientific paper
• Comparing clinical trials

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

• 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

• 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

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

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

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

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

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