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Healthcare Professionals

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Healthcare Professionals
Board Certified Medical Affairs Specialist (BCMAS) Canada

CoursesHealthcare ProfessionalsBoard Certified Medical Affairs Specialist (BCMAS) Canada

The Pharmaceutical Industry 1
- Lecture1.1
  
  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 Function, Drug Discovery: Research and Development (R&D), The Drug Development Process – Path to Drug Approval, Drug Advertising and Promotional Material, Generic Drugs, Staying Competitive; Artificial Intelligence, Blockchain Technology & Machine Learning in the Pharmaceutical Industry
Medical Device Industry 1
- Lecture2.1
  
  Introduction to the Medical Device Industry, Market Segmentation Categories, The Device Business Market, Exportation of Medical Devices, Challenges in Exporting Medical Devices, Factors Influencing the Medical Device Industry, Medical Device Regulatory High Points, Medical Device Pathway to Market, Digital Technology and the Medical Device Industry
Diagnostics Industry 1
- Lecture3.1
  
  The Diagnostics Industry, Segments of In Vitro Diagnostics (IVDs), Molecular Diagnostics, Point-of-Care (POC) Diagnostics, Regulation of IVDs, Classification of IVDs, Pharmacogenomics, Diagnostics and Medical Affairs
Rules Governing Interactions with Healthcare Professionals 1
- Lecture4.1
  
  The Importance of Interactions Between Pharma Companies and Healthcare Professionals (HCPs), Rules Governing the Interactions with HCPs, Training and Conduct of Company Representatives, Effectively Engaging HCPs, Impact of Medical Affairs on the Interactions of Companies with HCPs, KOL Mapping
Health Economics Outcome Research 1
- Lecture5.1
  
  Introduction to Health Economics Outcome Research (HEOR), Models of Pharmacoeconomic Analysis, Assessment of Costs and Outcomes, Conducting a Pharmacoeconomic Analysis, Health Outcome Research, Quality-of-Life Measures
Evidence-Based Medicine 1
- Lecture6.1
  
  What is Evidence-Based Medicine (EBM), Five Steps to Practice EBM, Study Designs, Evidence Hierarchy, Classification of Evidence and Literature Resources, Resources for Literature Research
Clinical Trial Designs 1
- Lecture7.1
  
  Introduction to Clinical Trials, Importance of Clinical Trials, Clinical Trial Structural Designs, Clinical Trial Hypothetical Designs, Clinical Trial Parameters, Statistical Analysis, Bias and Confounding in Research
Presentation and Communication Skills 1
- Lecture8.1
  
  Importance of Presentation Skills, The People: Who is Your Audience, Presentation Preparation, Communication Skills, Emotional Intelligence (EI) vs Intelligence Quotient (IQ), Tips for Preparing Slide Decks, Essentials of an Effective Presentation
Regulatory Affairs 1
- Lecture9.1
  
  Introduction to Regulatory Affairs, Regulatory Affairs in the Medical Device Industry, Medical Device Classification, Canadian and US Medical Device Filing Types, Regulatory Affairs in the Canadian Pharmaceutical Industry, Health Canada Drug Review Process, Inspections and Advertising
Compliance 1
- Lecture10.1
  
  Role of the Compliance Department in the Pharmaceutical Industry, Conducting Ethical Clinical Research, Good Clinical Practice, ICH Quality, Safety, and Multidisciplinary Guidelines, Good Laboratory Practice, Advertising Compliance, Compliance and Medical Affairs
Abstract and Medical Writing 1
- Lecture11.1
  
  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
Publication Practices 1
- Lecture12.1
  
  Introduction to Publications in Medical Affairs, Landmarks in Publications, Publications Work-flow, The Scientific Platform, Working with Authors
Drug Development Process 1
- Lecture13.1
  
  Phases of Drug Development Process (Discovery, Pre-Clinical, Clinical), Regulatory Submission and Approval, Post-Market Research, Drug Approval Applications, Drug Life Cycle Managemen
Medical Information 1
- Lecture14.1
  
  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, Preparing Medical Response Documents
Medical Science Liaisons and Field Based Medical Teams 1
- Lecture15.1
  
  Medical Science Liaisons: Here and Now, Introduction to Field Based Medical Teams and the Role of the MSL and Medical Advisor, 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; Digital Technology & CRM for Medical Affairs
Grant and Investigator-Initiated Study Funding and Process 1
- Lecture16.1
  
  Grants Process, Investigator Initiated Studies (IIS), Funding Opportunities and Sources
Advisory Boards 1
- Lecture17.1
  
  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
Post-Approval Studies 1
- Lecture18.1
  
  Purpose of Post-Approval Research, Advantages and Disadvantages of Post-Approval Research, Types of Post-Approval Studies, Ethics and Standards in Post-Approval Studies, Roles of Medical Affairs in Post-Approval Activities of Drugs
Risk Management Plans (RMP) 1
- Lecture19.1
  
  Introduction to RMPs, Examples of the Types of Risk RMPs Requirements Aim to Mitigate, Determining When a RMPs is Needed and When Health Canada Can Require Them, What the FDA Takes into Consideration When Identifying the Need for REMS, REMS Elements, Elements to Assure Safe Use (ETASU)
Medication Safety and Pharmacovigilance 1
- Lecture20.1
  
  Safety Signals, Adverse Events, Adverse Drug Reactions, Sources of ADR Reports, Collecting and Assessing Pharmacovigilance Data, Health Canada’s MedEffect Initiative

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Next Introduction to the Medical Device Industry, Market Segmentation Categories, The Device Business Market, Exportation of Medical Devices, Challenges in Exporting Medical Devices, Factors Influencing the Medical Device Industry, Medical Device Regulatory High Points, Medical Device Pathway to Market, Digital Technology and the Medical Device Industry

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