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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

Electives (Must successfully complete 16 Regulatory Affairs Certificate Program (RCP) Elective Units)
Course NameCE HoursProgram Units
Product Labeling
11/27/2002- 09/25/2016
Location: Online
ACPE 2.00, IACET 2.001.00
Regulatory Issues
11/19/2002- 09/25/2016
Location: Online
ACPE 4.00, IACET 4.001.00
Crisis Management
10/16/2002- 09/25/2016
Location: Online
ACPE 1.50, IACET 1.501.00
Development of a Clinical Study Report
03/13/2014- 12/31/2016
Location: Online
None Available4.00
Adverse Event Reporting Requirements: IND and Postmarketing
07/24/2014- 12/31/2016
Location: Online
None Available3.00
FDA’s Evolving Position on the Brief Summary and Adequate Directions for Use Guidance
05/01/2015- 12/31/2016
Location: Online
None Available1.00
Oversight of Clinical Monitoring: Trends and Strategies
05/07/2015- 12/31/2016
Location: Online
None Available3.00
Postmarketing Requirements: The Legal Framework, How They Are Issued, Sponsor Obligations, and Challenges to Overcome
05/22/2015- 12/31/2016
Location: Online
None Available1.00
Tutorial#33: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges, and Decision Criteria
-
Location:
IACET 3.252.00
A New Era of Open Dialog and Communication: The Impact of FDASIA, PDUFA V, and Critical Path Innovation Meetings
06/25/2015- 07/01/2016
Location: Online
None Available1.00
Overview of Drug Development in Japan
09/10/2015- 12/31/2016
Location: Online
None Available6.00
CSRC/DIA: Social Listening and Safety Surveillance—Enabling Opportunities for Cardiac Safety
11/04/2015- 12/31/2016
Location: Online
None Available1.00
Amarin vs. FDA: What is the Future of Off-Label Drug Communication and What Can We Do Now?
12/10/2015- 12/31/2016
Location: Online
None Available1.00
Part 4: CDC’s Treating for Two Initiative and Other Federal Efforts to Disseminate Data for Informed Clinical Decision Making in Pregnancy and Lactation
01/26/2016- 01/25/2017
Location: Online
None Available1.00
Art of Writing a Clinical Overview
02/11/2016- 01/31/2017
Location: Online
None Available6.00
DIA Statistics 2016 Forum
-
Location:
IACET 16.0010.00
Oversight of Clinical Monitoring: Trends and Strategies
05/03/2016- 05/05/2016
Location: Online
IACET 6.003.00
How to Prepare for a Safety Inspection
06/07/2016- 06/09/2016
Location: Online
IACET 6.004.00
DIA Latin America Regulatory Conference (LARC) 2016
06/26/2016- 06/27/2016
Location: Philadelphia, PA, United States
IACET 9.506.00
DIA 2016
06/26/2016- 06/30/2016
Location: Philadelphia, PA, United States
ACPE 15.75, CME 18.25, IACET 17.00, PMI 9.75, RN 18.2512.00
#20: The Sunshine Act: Understanding the Essentials of Compliance
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#23: How to Prepare for an FDA Inspection
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#30: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#43: Risk Management and Safety Communication Strategies
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#44: The Good Pharmacovigilance Practices in the EU: Global Applications
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 6.50, IACET 6.50, RN 6.504.00
#31: Preparing for a US FDA Advisory Committee Meeting
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#34: Ethical Issues in Clinical Trials
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#35: Stated Preference Methods and the Science of Patient Engagement
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
ACPE 3.25, CME 3.25, RN 3.252.00
#36: Global Identification of Medicinal Products: Applied Principles for Practical Implementation to Support Regulatory Compliance
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#41: A Rare Disease Program Case Study: Strategies for Successful Outcomes
06/26/2016- 06/26/2016
Location: Philadelphia, PA, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America, and Other Emerging Markets
08/08/2016- 08/09/2016
Location: Washington, DC, United States
IACET 13.008.00
Adaptive Design in Clinical Trials: When and How to Apply
09/12/2016- 09/13/2016
Location: Washington, DC, United States
IACET 13.508.00
Development of a Clinical Study Report
09/27/2016- 09/29/2016
Location: Online
IACET 6.004.00
Postmarketing Drug Safety and Pharmacovigilance
10/24/2016- 10/25/2016
Location: Philadelphia, PA, United States
ACPE 12.50, IACET 12.508.00
Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process
10/31/2016- 11/01/2016
Location: Washington, DC, United States
IACET 13.008.00