CME/CPE Credits IACET CEU Credits
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The BCMAS™ Provides CME/CPE Credits

Author: Suzanne Soliman, PharmD
Chief Academic Officer, Accreditation Council for Medical Affairs (ACMA)

Learning objectives

  • Identify the global needs driving the growth of the pharmaceutical 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

Agenda

This module explores the pharmaceutical industry’s (pharma’s) structure and function, the divisions within a pharmaceutical company, and the external factors governing the industry.

  • Introduction
  • History & Development
  • Publicly Traded vs. Private Companies
  • Global Needs Driving the Growth of the Pharma Industry
  • The Different Functions Within the Pharmaceutical Industry
  • Supply Chain
  • Regulatory Agencies
  • Pharmaceutical Industry Organization Structure and Function
  • The Drug Development Process – Path to Drug Approval
  • Drug Advertising
  • Generic Drugs
  • Reporting Problems
  • Active Surveillance
  • Staying Competitive

Learning objectives

  • Describe various segments of diagnostics industry and how it differs from the pharmaceutical and medical device industries
  • Compare and contrast the different types of diagnostics tests (diagnostic segments)
  • Discuss the most common in vitro diagnostic tests (diagnostic segments)
  • Compare and contrast the advantages and disadvantages of point of care diagnostics
  • Recognize the regulations of in vitro diagnostics
  • List the FDA requirements for IVD products

Agenda

This module explores the pharmaceutical industry’s (pharma’s) structure and function, the divisions within a pharmaceutical company, and the external factors governing the industry.

  • Introduction
  • History & Development
  • Publicly Traded vs. Private Companies
  • Global Needs Driving the Growth of the Pharma Industry
  • The Different Functions Within the Pharmaceutical Industry
  • Supply Chain
  • Regulatory Agencies
  • Pharmaceutical Industry Organization Structure and Function
  • The Drug Development Process – Path to Drug Approval
  • Drug Advertising
  • Generic Drugs
  • Reporting Problems
  • Active Surveillance
  • Staying Competitive

Learning objectives

  • Define models of pharmacoeconomic analysis
  • Compare and contrast cost benefit effectiveness analysis
  • Describe direct and indirect costs and the concept of discounting
  • Compare and contrast assessment of costs
  • Assess health outcomes assessment studies
  • Describe the steps involved in the analysis of pharmacoeconomic studies

Agenda

This module explores the pharmaceutical industry’s (pharma’s) structure and function, the divisions within a pharmaceutical company, and the external factors governing the industry.

  • Introduction
  • History & Development
  • Publicly Traded vs. Private Companies
  • Global Needs Driving the Growth of the Pharma Industry
  • The Different Functions Within the Pharmaceutical Industry
  • Supply Chain
  • Regulatory Agencies
  • Pharmaceutical Industry Organization Structure and Function
  • The Drug Development Process – Path to Drug Approval
  • Drug Advertising
  • Generic Drugs
  • Reporting Problems
  • Active Surveillance
  • Staying Competitive

Learning objectives

  • Define First Tier quality system-related requirements and “Compliance” in the context of compliance quality systems for drugs, biologics, and medical devices
  • Define Second Tier quality system-related requirements and “Compliance” in the context of the: 21 Code of Federal Regulations (CFR) Part 50 – Protection of Human Subjects Domestic; 21 CFR Part 56 – Institutional Review Board International; and 21 CFR Part 58 – Good Laboratory Practice for Non-Clinical Laboratory Studies
  • Describe a plan for the Compliance and Third Tier-related requirements, including CFR Part 7 – Enforcement Policy

Agenda

This module explores the pharmaceutical industry’s (pharma’s) structure and function, the divisions within a pharmaceutical company, and the external factors governing the industry.

  • Introduction
  • History & Development
  • Publicly Traded vs. Private Companies
  • Global Needs Driving the Growth of the Pharma Industry
  • The Different Functions Within the Pharmaceutical Industry
  • Supply Chain
  • Regulatory Agencies
  • Pharmaceutical Industry Organization Structure and Function
  • The Drug Development Process – Path to Drug Approval
  • Drug Advertising
  • Generic Drugs
  • Reporting Problems
  • Active Surveillance
  • Staying Competitive

These have been designated Knowledge (K)-type activities

Target Audience

Physicians, pharmacists, and PhDs who work in Medical Affairs in the pharmaceutical industry.

Cost to participate

$99 (you have already paid)

For Physicians

Maximum of 5.00 AMA PRA Category 1 Credit(s)™

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of ScientiaCME and the Accreditation Council for Medical Affairs. ScientiaCME is accredited by the ACCME to provide continuing medical education for physicians. ScientiaCME designates this enduring material for a maximum of 5.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

For Pharmacists

ScientiaCME designates the following modules within the BCMAS program for continuing education activity for a maximum of 5.00 contact hour(s) (0.5 CEUs). These modules are listed below:

  • Pharmaceutical Industry Overview: 0574-9999-20-047-H04-P: 2.00 contact hours (0.2 CEUs)
  • Diagnostics Industry: 0574-9999-20-048-H04-P: 1.00 contact hour (0.1 CEU)
  • Health Economics Outcomes Research: 0574-9999-20-049-H04-P: 1.00 contact hour (0.1 CEU)
  • Compliance: 0574-9999-20-050-H03-P: 1.00 contact hour (0.1 CEU) *
* May be used to satisfy pharmacy law CEU requirements in states that require it.

Instructions for Participation and Credit

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 80% on the post-test.

Follow these steps to earn CME/CPE/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test.
  4. Once you have completed the program, you can print the certificate from online. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.
  5. Pharmacists: must provide their dates of birth (MMDD) and NABP e-ID numbers to ACMA either before successfully passing the post-test or within one month after doing so. The CPE statement provided contains information provided to NABP from the Accreditation Council for Pharmacy Education (ACPE) via CPE Monitor®. ACPE policy states paper and/or electronic statement of credit may no longer be distributed directly to learners as proof of ACPE credit. The official record of credit may be located in the learner’s e-profile in CPE Monitor®.

*The credit that you receive is based on your username profile.

Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact CME@medicalaffairsspecialist.org.

These learning activities are being provided jointly by ACMA and ScientiaCME. ScientiaCME is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This activity is provided free of commercial support.

Release date: 10/01/2020

Expiration date: 9/30/2021

All CME/CE is provided in conjunction with our partner ScientiaCME. For more information or questions regarding our accredited programs, please email us at info@acmainfo.org.

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The BCMAS Program Provides IACET CEUs

IACET Statement of Accreditation

The Accreditation Council for Medical Affairs is accredited by the International Association for Continuing Education and Training (IACET). The Accreditation Council for Medical Affairs complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, the Accreditation Council for Medical Affairs is authorized to issue the IACET CEU.

IACET CEU Credit Statement

As an IACET Accredited Provider, the Accreditation Council for Affairs offers CEUs for its programs that qualify under the ANSI/IACET Standard. The Accreditation Council for Medical Affairs is authorized by IACET to offer 8.0 CEUs for the BCMAS program. Note: All target audience members are eligible for continuing education credit upon successful completion of this course. This course does not issue certificates of attendance and does not award partial Joint Accreditation (JA) or IACET CEU continuing education credit certificates for partial completion.

Any questions regarding acceptance of JA continuing education credits by credentialing bodies, boards, or professional organizations or associations must be submitted directly to those entities.

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