Regulatory Affairs

DIA's Regulatory Affairs Certificate Program provides you with comprehensive training on current regulations and their practical application to the development and commercialization of pharmaceutical, biotechnology, medical device, and related health care products. Enroll today!

Features and Benefits

DIA has been an established authority in the pharmaceutical industry for more than 48 years.
As an independent, not-for-profit, global association of members with no corporate sponsors, DIA offers an objective program that results in a DIA Certificate of Completion.
Many courses offer Continuing Education Credits.

What You Will Learn:

US regulatory affairs: the IND and NDA phases
EU regulatory requirements
Preparing for FDA meetings
Post-approval regulatory requirements
Regulatory requirements for product labeling & advertising
Regulatory courses covering drug, medical device, and biologic products
Quality assurance
Much more!

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Program Requirements

Certificate Program Requirements

Core (Must successfully complete 28 Regulatory Affairs Certificate Program (RCP) Core Units)

Core details HideView

Course Name	CE Hours	Program Units
Basics of the NDA 05/20/2013- 05/31/2013 Location: Online	IACET 9.00	6.00
Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling 06/04/2013- 06/04/2013 Location: Online	IACET 2.00	2.00
#57: Preparing for a US FDA Advisory Committee Meeting 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 5.25	4.00
Interactions with the FDA During the IND/NDA Phases 07/23/2013- 07/25/2013 Location: Online	IACET 2.00	2.00
Regulatory Affairs: The IND, NDA, and Postmarketing 08/12/2013- 08/15/2013 Location: Boston, MA, United States	IACET 29.50	16.00
Regulatory Affairs for Biologics 09/23/2013- 09/24/2013 Location: Horsham, PA, United States	IACET 11.75	8.00
Basics of the IND 10/01/2013- 10/10/2013 Location: Online	IACET 8.25	6.00
Basics of the NDA 10/22/2013- 10/31/2013 Location: Online	IACET 9.00	6.00
Preparing for a US FDA Advisory Committee Meeting 11/10/2013- 11/10/2013 Location: Philadelphia, PA, United States	IACET 5.25	4.00
Regulatory Affairs: The IND, NDA, and Postmarketing 11/11/2013- 11/14/2013 Location: Philadelphia, PA, United States	IACET 29.50	16.00

Electives (Must successfully complete 16 Regulatory Affairs Certificate Program (RCP) Elective Units)

Electives details HideView

Course Name	CE Hours	Program Units
Crisis Management 10/16/2002- 09/25/2013 Location: Online	ACPE 1.50, IACET 1.50	1.00
Product Labeling 11/27/2002- 09/25/2013 Location: Online	ACPE 2.00, IACET 2.00	1.00
Regulatory Issues 11/19/2002- 09/25/2013 Location: Online	ACPE 4.00, IACET 4.00	1.00
Assessing the Benefits and Risks of Medicines: Webinar Series-Part 6: Multi-criteria Decision Analysis to Assist in the Decision Making Process 05/22/2013- 05/22/2013 Location: Online	ACPE 1.50, IACET 1.50	1.00
Certificates of Pharmaceutical Products for Regulatory Submissions 05/23/2013- 05/23/2013 Location: Online	IACET 2.00	1.00
FDA and the Freedom of Information Act: The Unredacted Story 05/30/2013- 05/30/2013 Location: Online	IACET 1.50	1.00
Drug & Cosmetic Rule Amendments: Changes in Regulations Governing Clinical Trials in India 06/06/2013- 06/06/2013 Location: Online	IACET 1.50	1.00
Assessing the Benefits and Risks of Medicines: Webinar Series- Part 7: A Structured, Quantitative Health Outcomes Approach to Drug Benefit-Risk Analysis 06/12/2013- 06/12/2013 Location: Online	ACPE 1.50, IACET 1.50	1.00
Supplements and Other Changes to an Approved Application 06/12/2013- 06/12/2013 Location: Online	IACET 1.00	1.00
DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science 06/23/2013- 06/27/2013 Location: Boston, MA, United States	ACPE 18.00, CME 18.00, IACET 24.00, PMI 12.00, RN 18.00	12.00
#20: Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 3.25	2.00
#21: FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 3.25	2.00
#23: A Device Primer: 510(k)s, PMAs, IDEs 06/23/2013- 06/23/2013 Location: Boston, MA, United States	CME 3.25, IACET 3.25	2.00
#32: Understanding Translational Medicine: Benefits and Innovative Approaches 06/23/2013- 06/23/2013 Location: Boston, MA, United States	CME 3.25, IACET 3.25	2.00
#34: Fourteen Steps from Research to Development 06/23/2013- 06/23/2013 Location: Boston, MA, United States	CME 3.25, IACET 3.25	2.00
#35: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions and Regulatory Document Writing 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 3.25	2.00
#50: Understanding and Navigating the Regulatory System in China 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 6.50	4.00
#52: Regulatory Affairs for Biologics 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 6.50	4.00
#54: Art of Writing a Clinical Overview 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 6.50	4.00
#55: Overview of Drug Development 06/23/2013- 06/23/2013 Location: Boston, MA, United States	IACET 6.50, PMI 6.50	4.00
New Good Pharmacovigilance Practice (GVP) documents in Canada 07/17/2013- 07/17/2013 Location: Online	IACET 1.50	1.00
Regulating a Social World 07/18/2013- 07/18/2013 Location: Online	IACET 1.50	1.00
Assessing the Benefits and Risks of Medicines: Webinar Series- Part 8: Visualization and Communication of Benefit-Risk 07/24/2013- 07/24/2013 Location: Online	ACPE 1.50, IACET 1.50	1.00
Adverse Event Reporting Requirements: IND and Postmarketing 07/30/2013- 08/01/2013 Location: Online	IACET 4.50	3.00
Strategies for Good Clinical Practice Audits 09/09/2013- 09/17/2013 Location: Online	IACET 7.50, RN 7.50	4.00
Art of Writing a Clinical Overview 09/09/2013- 09/09/2013 Location: Horsham, PA, United States	IACET 6.75	4.00
Clinical Trial Disclosure: Towards a More Transparent World 10/01/2013- 10/02/2013 Location: Bethesda, MD, United States	IACET 12.00	8.00
Developing Global Animal Health Products to Support Food Security and Sustainability 10/17/2013- 10/18/2013 Location: Arlington, VA, United States	IACET 13.00	7.00
Global Considerations for Regulatory Strategy Development 10/17/2013- 10/18/2013 Location: Horsham, PA, United States	IACET 12.50	8.00

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Regulatory Affairs

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Certificate Program Requirements