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Regulatory Affairs

Comprehensive training on current regulations and their practical application

This certificate program will provide the fundamental skills you need to do your job. Topics include but are not limited to:

  • US regulatory affairs: the IND and NDA and postmarketing
  • European regulatory requirements
  • Preparing for FDA meetings
  • Post-approval regulatory requirements
  • Regulatory requirements for product labeling & advertising
  • Electronic submissions
  • Quality assurance
  • Biosimilars
  • Biologic products
  • Drug development
Certificate Program Requirements
To successfully complete the certificate program, learners must complete 28 Core units and 16 Elective units; courses included in this program are noted below:

Course Title
Format
PM Certificate Program Units

Adverse Event Reporting Requirements: IND and Post-marketing

Online
3 Elective Units
Art of Writing a Clinical Overview
Online and Face-to-face
4 Elective Units
Basics of the IND

Online
6 Core Units

Basics of the NDA

Online
6 Core Units
Development of a Clinical Study Report
Online and Face-to-face
4 Elective Units

Electronic Submissions: The Next Era of Electronic Submissions

Face-to-face
4 Elective Units
European Regulatory Affairs: Keeping your Finger on the Pulse of Marketing Authorizations
Face-to-face
6 Core Units

Global Considerations for Regulatory Strategy Development

Face-to-face
8 Elective Units

How to Prepare for a Safety Inspection

Online
3 Elective Units

Interactions with the FDA during the IND/NDA Phases

Online
2 Core Units

Key Considerations for the Development and Marketing of Biosimilar Products

Face-to-face
8 Elective Units
Navigating Chemistry, Manufacturing and Controls Through the Drug Development Process
Face-to-face
8 Elective Units

Overview of Drug Development

Face-to-face
4 Elective Units

Overview of Drug Development in Japan

Online
6 Elective Units

Preparing for a US FDA Advisory Committee Meeting

Face-to-face
4 Core Units

Regulatory Affairs for Biologics

Face-to-face
8 Core Units

Regulatory Affairs: The IND, NDA and Postmarketing

Face-to-face
16 Core Units
Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling
Online
2 Core Units

Strategies for Good Clinical Practice Audits

Online
4 Elective Units

Supplements and Other Changes to an Approved Application

Online
1 Elective Unit
* additional meetings and webinars are available to meet the elective unit requirements and will be noted in the upcoming schedule list below

Downloads

Certificate Program Requirements

Core (Must successfully complete 28 Regulatory Affairs Certificate Program (RCP) Core Units)
Course NameCE HoursProgram Units
European Regulatory Affairs: In-depth review of current registration procedures in the European Union
-
Location:
None Available6.00
US Regulatory Affairs: A Comprehensive Review of Regulatory Procedures for INDs and NDAs in the US
-
Location:
None Available16.00
Basics of the NDA Phase
05/21/2015- 06/30/2017
Location: Online
IACET 6.006.00
Basics of the IND
05/12/2016- 05/24/2017
Location: Online
IACET 6.006.00
Interactions with the FDA During the IND/NDA Phases
05/18/2016- 05/10/2017
Location: Online
IACET 2.002.00
Regulatory Affairs: The IND, NDA, and Postmarketing
03/20/2017- 03/23/2017
Location: San Diego, CA, United States
ACPE 28.25, IACET 28.2516.00
Regulatory Affairs for Biologics
04/05/2017- 04/06/2017
Location: Washington, DC, United States
IACET 13.008.00
Interactions with the FDA During the IND/NDA Phases
05/04/2017- 05/04/2017
Location: Online
IACET 2.002.00
Basics of the IND
05/15/2017- 05/18/2017
Location: Online
IACET 6.006.00
Regulatory Affairs: The IND, NDA, and Postmarketing
08/14/2017- 08/17/2017
Location: Boston, MA, United States
ACPE 28.25, IACET 28.2516.00
European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations
08/16/2017- 08/17/2017
Location: Boston, MA, United States
ACPE 14.50, IACET 14.506.00
Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling
09/21/2017- 09/21/2017
Location: Online
IACET 2.002.00
Regulatory Affairs: The IND, NDA, and Postmarketing
10/23/2017- 10/26/2017
Location: Philadelphia, PA, United States
ACPE 28.25, IACET 28.2516.00

Electives (Must successfully complete 16 Regulatory Affairs Certificate Program (RCP) Elective Units)
Course NameCE HoursProgram Units
Tutorial#33: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges, and Decision Criteria
-
Location:
IACET 3.252.00
Overview of Drug Development in Japan
-
Location:
IACET 6.006.00
Art of Writing a Clinical Overview
02/11/2016- 03/01/2017
Location: Online
IACET 6.006.00
Oversight of Clinical Monitoring: Trends and Strategies
05/05/2016- 05/17/2017
Location: Online
IACET 6.003.00
Development of a Clinical Study Report
10/25/2016- 07/26/2017
Location: Online
IACET 6.004.00
How to Prepare for a Safety Inspection
06/09/2016- 06/14/2017
Location: Online
IACET 6.004.00
Art of Writing a Clinical Overview
03/02/2017- 03/02/2018
Location: Online
IACET 6.006.00
Introduction to Signal Detection and Data Mining
04/07/2017- 04/07/2017
Location: Washington, DC, United States
ACPE 6.00, IACET 6.004.00
Oversight of Clinical Monitoring: Trends and Strategies
05/09/2017- 05/11/2017
Location: Online
IACET 6.003.00
How to Prepare for a Safety Inspection
06/06/2017- 06/08/2017
Location: Online
IACET 6.004.00
#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing
06/18/2017- 06/18/2017
Location: Chicago, IL, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#22: How to Prepare for an FDA Inspection
06/18/2017- 06/18/2017
Location: Chicago, IL, United States
CME 3.25, IACET 3.25, RN 3.252.00
#30: Preparing for a US FDA Advisory Committee Meeting
06/18/2017- 06/18/2017
Location: Chicago, IL, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
Development of a Clinical Study Report
07/18/2017- 07/20/2017
Location: Online
IACET 6.004.00
Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets
09/14/2017- 09/15/2017
Location: Washington, DC, United States
ACPE 13.00, IACET 13.008.00
Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process
09/18/2017- 09/19/2017
Location: Washington, DC, United States
IACET 13.258.00
Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation
10/02/2017- 10/03/2017
Location: Washington, DC, United States
IACET 13.258.00
Adaptive Design in Clinical Trials: When and How to Apply
11/09/2017- 11/10/2017
Location: Washington, DC, United States
IACET 13.508.00