The Medical Affairs Competency Certificate (MACC) Program

The Medical Affairs Competency Certificate (MACC) Program offers an introduction to the field of medical affairs for students & professionals with an interest to understand the fundamentals of the pharmaceutical industry focused specifically on clinical development and medical affairs.

There are no specific degree or license requirements for the program.

The MACC is ideal for those who wish to demonstrate core competencies in Medical Affairs.

Eligibility:

Anyone is eligible to take the course.

Exam:

There is no examination required to complete the program.

The program covers the following:

Pharmaceutical Industry Overview

Rules Governing Interactions with Healthcare Professionals (HCPs)

Regulatory Affairs

Compliance

Drug Development Process

Medical Science Liaisons & Field Based Medical Teams

To learn more about each module click on the module below.

1. The Pharmaceutical Industry Overview CME / CE

   Explores the pharmaceutical industry’s (pharma) structure and function, the divisions within a pharmaceutical company, and the external factors governing the industry. Explains all of the functions within the industry and economic implications.

   Learning Objectives: 

   • Identify the global needs driving the growth of the pharma industry
   • Compare and contrast the different functions (medical affairs, legal, regulatory, clinical operations, clinical development, and commercial) within the pharmaceutical industry
   • Define the drug development process and path to approval
   • Recognize the role that the supply chain process plays in ensuring that pharmaceutical products are delivered to patients in both a timely manner and with high quality assurance
   • Describe the primary function of health economics outcomes research
2. Rules Governing Interactions with Healthcare Professionals

   This module explains in detail how the interaction between pharma companies and HCPs are crucial elements for the benefits of not only the companies but also the patient populations and the healthcare system in general. It also provides a comprehensive overview related to the applicable laws and industry standards regarding the nature of interaction between how medical affairs personnel (as well as pharma in general) should be interacting with healthcare providers (HCPs).

   Learning Objectives:

   • Describe the purposes of interactions of pharma companies with HCPs (purposes of interactions, benefits of interaction)
   • Evaluate different rules governing interactions with HCPs
   • Recognize the impact of Medical Affairs on the overall relationships of companies with HCPs
   • Compare and contrast proactive vs reactive discussions (use case study here)
   • Define PHRMA (Pharmaceutical Research and Manufacturers of America) code regulations related to meals for physicians
   • Compare and contrast speaker programs vs CME events
   • Identify the Prescription Drug Marketing Act is and its applicability
   • Describe the Sunshine Act and its applicability
   • Recall the rules for accessing prescriber data
3. Regulatory Affairs

   The goal of this module is to provide you with an overview of the Regulatory Affairs function within a pharmaceutical company, both domestically and internationally. The module will discuss the different filings and consideration for medical devices, as well as pharmaceuticals in the United States and in the international community.

   Learning Objectives:

   • Describe regulatory affairs for medical devices
   • Compare and contrast clearance versus approval
   • Define a 510(k)
   • Identify an IDE and the different types
   • Evaluate the medical device classifications and regulatory affairs for the US, Canada, and the EU
   • Describe the role of OPDP
4. Compliance CME / CE

   This module provides you with the compliance rules, regulations, and functions within a pharmaceutical company for both drug and drug products, and medical devices. The module first discusses the different compliance issues specific to drugs and drug products. Then it presents compliance issues specific to medical devices. The information presented here is important to consider when engaging in clinical development or clinical trials within medical affairs.

   Learning Objectives:

   • Define Compliance and First Tier quality system related requirements
   • Compliance quality system for Drugs and Biologics
   • Compliance quality system for Medical Devices
   • Describe Compliance and Second Tier related requirements
   • 21 Code of Federal Regulations (CFR) Part 50 – Protection of Human Subjects Domestic
   • 21 CFR Part 56 – Institutional Review Board International
   • 21 CFR Part 58 – Good Laboratory Practice for Non-Clinical Laboratory Studies
   • Organize a plan for the Compliance and Third Tier related requirements
   • CFR Part 7 – Enforcement Policy

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5. Drug Development Process

   This module provides an in-depth explanation of how a compound evolves from the initial discovery stage to the marketplace, detailing the requirements for each phase in the development cycle.

   Learning Objectives:

   • Recognize each stage in the drug development process
   • Compare & contrast what happens in different phases of drug development
   • Identify different types of applications required for drug approval
   • Compare and contrast an IND vs NDA
   • Describe how pharmaceutical companies manage a drug’s life cycle after the drug successfully launches the market
   • Identify the situations in which the FDA will fast track a medication. (e.g., rare/orphan diseases)
   • Define the components of a biological license application(BLA).
6. Medical Science Liaisons & Field Based Medical Teams

   This module provides you with an overview of the role of the medical science liaison (MSL) and field-based medical teams. It discusses the typical responsibilities of the MSL, as well as the evolution of its specialization to developing and managing relationships between key experts while leveraging expectations by partner companies. In addition, it reviews territory management in relation to key opinion leader (KOL) strategy, review KOL interactions, distinguishes between local, regional and national KOLs. Examples of interaction metrics and how they deliver comprehensive analytics and reports to assess the job that the MSL plays in the field are also provided. Lastly, it discusses MSL responsibilities in the investigator sponsored research process and other core competencies that MSLs deliver within their position.

   Learning Objectives:

   • Describe the roles MSL plays within the greater pharmaceutical organization
   • Compare & contrast different types of KOLs within different regions
   • List the rules governing interactions with MSLs, sales teams and key company stakeholders
   • Describe the main functions and job duties of MSLs
   • Identify core competencies required to excel in an MSL position
   • Describe the regulatory guidelines impacting MSLs
   • Describe the role MSL plays in Investigator Sponsored Research