Board Certified Medical Affairs Specialist Program (BCMAS) – Independent Credentialing in Medical Affairs
For example, John Doe, PharmD, BCMAS.
CME Accredited board certification program
Immediate application to the workplace
Flexible self-paced, online program (takes approximately 6-8 weeks to complete)
Each module contains an overview, case studies, knowledge check questions, and a glossary to help guide you through each topic.
Completing the BCMAS program translates into an opportunity for you to be distinguished among your peers in the pharmaceutical industry.
Demonstrate your desire and ambition to pursue the highest level of accreditation within medical affairs
Establish your long term commitment to the highest standards of excellence in your field
Expand your career options and increase your opportunities in the pharmaceutical and health care sector.
To be eligible for the BCMAS program, you must:
Hold an MD, DO, PhD (life or physical sciences), or PharmD from an accredited institution.
Be successfully matriculated in a doctoral level program (MD, DO, PhD, PharmD) within an accredited institution.
Foreign Medical Graduates are eligible.
The Credentialing Committee will make the final determination on your eligibility.
Introduction to the Pharmaceutical Industry, History and Development, Publicly Traded vs.Private Companies, Global Needs Driving the Growth of the Pharma Industry, The Different Functions Within the Pharmaceutical Industry (Drug Manufacturing, Supply Chain, Regulatory Agencies, International Regulatory Bodies), Pharmaceutical Industry Organizational Structure and Organization Function, Drug Discovery: Research and Development (R&D), The Drug Development Process – Path to Drug Approval, Drug Advertising, Generic Drugs, Problem Reporting, Active Surveillance, Staying Competitive
Introduction to the Medical Device Industry, Market Segmentation Categories, The Device Business Market, Exportation of Medical Devices, Global Market Growth Drivers, US Medical Device Industry Constraints, Medical Device Regulatory High Points, Medical Device Pathway
The Diagnostics Industry, Segments of In Vitro Diagnostics (IVDs), Molecular Diagnostics, Point-of-Care (POC) Diagnostics, Regulation of IVDs, Classification of IVDs
The Importance of Interactions of Pharma Companies with Healthcare Professionals (HCPs), Rules Governing the Interactions with HCPs, Independence and Decision Making, Training and Conduct of Company Representatives, Physician Payments Sunshine Act, Impacts of Medical Affairs on the Interactions of Companies with HCPs
Introduction to Health Economics Outcome Research (HEOR), Models of Pharmacoeconomics, Assessment of Costs and Outcomes, Conducting a Pharmacoeconomic Analysis, Health Outcome Research, Quality-of-Life Measures
What is Evidence-Based Medicine (EBM), Five Steps to Practice EBM, Study Designs, Evidence Hierarchy, Classification of Literature Resources
Introduction to Clinical Trials, Importance of Clinical Trials, Clinical Trial Structural Designs, Clinical Trial Hypothetical Designs, Clinical Trial Parameters, Statistical Analysis, Diagnostics Tests, Bias and Confounding in Research
Importance of Presentation Skills, The People: Who is Your Audience, Presentation Preparation, Communication Skills, Emotional Intelligence (EI) vs Intelligence Quotient (IQ)
Tiers of Compliance Regulations, First Tier Compliance Regulations and Subparts (FDA 21 CFR Parts 210 Current Good Manufacturing Practices for Manufacturing, FDA 21 CFR Parts 211 Current Good Manufacturing Practices for Finished Products, FDA 21 CFR Parts 280 Quality System Regulation for Good Manufacturing Practices), Second Tier Compliance Regulations and Subparts (FDA 21 CFR Part 50 Protection of Human Subjects, FDA 21 CFR Part 56 Institution Review Board, FDA 21 CFR Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies (GLPs)), Third Tier Compliance Regulations and Subparts (FDA 21 CFR Part 7 Enforcement Policy)
Introduction to Abstracts, Purpose of Writing an Abstract, Types of Abstracts, Effective Abstract Writing for Scientific/Research Papers, Components of the Abstract, Medical Writing in the Health Care Industry, Types of Medical Writing, General Steps in Writing Scientific Documents
Introduction to Publications in Medical Affairs, Landmarks in Publications, Publications Workflow, The Scientific Platform, Working with Authors
Phases of Drug Development Process (Discovery, Pre-Clinical, Clinical), Regulatory Submission and Approval, Post-Market Research, Drug Approval Applications, Drug Life Cycle Management
Medical Information: Here and Now, Structure, Roles Within Medical Information, Medical Information Stakeholders, Medical Information Core Responsibilities, Scientific Review Committee, MI Key Challenges and Opportunities
Medical Science Liaisons: Here and Now, Introduction to Field Based Medical Teams and the Role of the MSL, Key Opinion Leaders, Geographic Coverage by MSL Teams, Roles Within an MSL Organization, Communication and Meeting Preparation, Networking and KOL Identification, Clinical Research Support, Maintaining Scientific Accuracy and Product Initiative Support, MSL Key Challenges and Opportunities
Grants Process, Investigator Initiated Studies (IIS), Funding Opportunities and Sources
Role of Advisory Boards, Challenges and Key Elements to the Success of Advisory Boards, Members of Advisory Boards, Value of Advisory Boards in Changing the Landscape of Medical Affairs
Purpose of Post-Marketing Research, Advantages and Disadvantages of Post-Market Research, Types of Post-Marketing Studies, FDA-Mandated vs Non-FDA-Mandated, Roles of Medical Affairs in Post-Marketing Activities of Drugs
Introduction to Regulatory Affairs, Regulatory Affairs in the Medical Device Industry, Medical Device Classification, Performance Standards, Medical Device Filing Types, Regulatory Affairs in the US Pharmaceutical Industry, Regulatory Affairs in the EU and Canadian Pharmaceutical Industries
Introduction to REMS, Examples of the Types of Risk REMS Requirements Aim to Mitigate, Determining When a REMS is Needed, What the FDA Takes into Consideration When Identifying the Need for REMS, REMS Elements, Elements to Assure Safe Use (ETASU)
Safety Signals, Adverse Events, Adverse Drug Reactions, FDA Pre-Market and Post-Market Safety
|Application Fee (Non-refundable)||$49|
|Board Certified Medical Affairs Specialist Program||$1000|
|Examination Fee *||$850|
The BCMAS program must be completed within six months of acceptance into the program.
The examination is of intermediate difficulty. It is meant to assess your core competencies in the areas covered within the BCMAS program.
Once you enroll in the BCMAS program, you have up to 6 months to complete the program. Because the entire program is online, you can work at your own pace & comfort level to complete the program. If you require an extension, you will need to make a written appeal to our chief academic officer who will make the final decision. There may be a fee associated with extensions granted.
It will be a BCMAS professional designation. For example, John Doe, PharmD, BCMAS.
The BCMAS exam can be taken up to 4 times before needing to file a new application. If a candidate fails the exam on the fourth try, there will be a waiting period of 1 year before retaking the exam up to four more times. The reexamination fee is $250
Results will be available within 1-3 business days via email. Board Certificates are mailed out on a quarterly basis.
For example, to receive your certificate within the quarter you must complete your board exam within 10 days prior to the ending of that quarter. Q1: January-March, Q2: April-Jun, Q3: Jul-Sep, Q4: Oct-Dec.
*A calendar quarter runs from January to March, April to June, July to September, and October to December
The candidate can take the exam anywhere, anytime. It is available on the program’s Learning Management System (LMS). The exam tab will be enabled once the candidate has completed all the module quizzes. In order to sit for the exam, the candidate will need to schedule a proctoring session via ProctorU (the online proctoring service provider) 72 hours before the desired date. All the instructions on how to schedule a proctoring session is be available on the examination page.
Yes, you are still eligible as long as you can provide evidence that your school is certified by the Educational Commission for Foreign Medical Graduates (ECFMG).
The exam is offered asynchronously. That is, the candidate may sit for the exam anytime, anywhere as long as the candidate has access to the BCMAS program’s Learning Management System (LMS).
In order to protect the integrity of the BCMAS program, no exam questions or the answer key will be released to any individual or organization.
For more questions please email us at email@example.com
Becoming a board certified Medical Affairs specialist demonstrates your professional accomplishment and growth, and validates competence, knowledge, dedication, and commitment to best practices and standards in the field of Medical Affairs. Competence includes both cognition and behaviors, and can be defined as the ongoing ability to integrate and apply the knowledge, skills, judgment, and values to excel in Medical Affairs.
After initial certification, the ACMA encourages you to continue activities essential to the maintenance of knowledge and continuing competence required for their level of practice and certification. With new technology, strategies, and research comes change. Renewal of certification assures that those holding the BCMAS credential have maintained knowledge and competence, and are up-to-date with the latest advances in the field.
The ACMA requires that all BCMAS professionals renew their certification every 5 years to maintain active status. Those who do not renew their certification, must cease using the BCMAS credential after the associated expiration date. The cost for recertification is $500.00.
There are two options for re-certification: