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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

Certificate Program Requirements

Electives (Must successfully complete 16 Regulatory Affairs Certificate Program (RCP) Elective Units)
Course NameCE HoursProgram Units
Crisis Management
10/16/2002- 09/25/2016
Location: Online
ACPE 1.50, IACET 1.501.00
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
CDER Town Meeting: Safety Hot Topics
01/29/2014- 07/28/2014
Location: Online
None Available1.00
The Use of Mobile Medical Applications as Companions
02/12/2014- 02/11/2015
Location: Online
None Available1.00
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/24/2015
Location: Online
None Available1.00
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/24/2015
Location: Online
None Available1.00
Seven-Part Series on Pediatric Drug Development - Part 1: Overall Challenge: The Vision of Better Medicines for Children
04/16/2014- 10/13/2015
Location: Online
None Available1.00
A Model of Patient, Payer, and Product Developer Collaboration to Support Innovating for Value
-
Location:
IACET 9.256.00
Good Pharmacovigilance Practice: How Good has it Proven to be for Industry?
04/29/2014- 04/29/2014
Location: Online
IACET 1.501.00
Designed for Success: Utilizing Protocol Quality by Design (QbD) to Plan Clinical Studies
05/01/2014- 05/01/2014
Location: Online
IACET 1.501.00
Global Considerations for Regulatory Strategy Development
05/05/2014- 05/06/2014
Location: Horsham, PA, United States
IACET 12.508.00
How to Prepare for a Safety Inspection
05/06/2014- 05/08/2014
Location: Online
IACET 6.003.00
Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline
05/07/2014- 05/09/2014
Location: North Bethesda, MD, United States
ACPE 16.50, CME 16.50, IACET 16.5010.00
Big Data: Impact of Health Care Reform on Collaborations and Strategies
05/19/2014- 05/19/2014
Location: Online
IACET 1.501.00
Seven-Part Series on Pediatric Drug Development - Part 2: Regulatory Framework, US
05/20/2014- 05/20/2014
Location: Online
ACPE 1.50, IACET 1.501.00
Seven-Part Series on Pediatric Drug Development - Part 3: Regulatory Framework EU
06/10/2014- 06/10/2014
Location: Online
ACPE 1.50, IACET 1.501.00
Supplements and Other Changes to an Approved Application
06/10/2014- 06/10/2014
Location: Online
IACET 1.001.00
#31: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges and Decision Criteria
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
IACET 3.252.00
#32: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#33: Bayesian Evidence Synthesis and Network Meta-analysis
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#35: Understanding Translational Medicine: Benefits and Innovative Approaches
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#42: Regulatory Affairs for Biologics
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
IACET 6.504.00
#45: Risk Management Plan
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"
-
Location:
ACPE 18.00, CME 18.00, IACET 24.00, PMI 15.00, RN 18.0012.00
#20: Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
IACET 3.252.00
#21: The Sunshine Act: Understanding the Essentials of Compliance
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#22: Preparing for a US FDA Advisory Committee Meeting
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
IACET 3.252.00
Seven-Part Series on Pediatric Drug Development - Part 4: Dosing in Children
07/08/2014- 07/08/2014
Location: Online
ACPE 1.50, IACET 1.501.00
Adverse Event Reporting Requirements: IND and Postmarketing
07/22/2014- 07/24/2014
Location: Online
IACET 4.503.00
Seven-Part Series on Pediatric Drug Development - Part 5: Technical Development: Pediatric Formulations
08/12/2014- 08/12/2014
Location: Online
ACPE 1.50, IACET 1.501.00
Overview of Drug Development
09/08/2014- 09/08/2014
Location: Horsham, PA, United States
IACET 6.50, PMI 6.504.00
Key Considerations for the Development and Marketing of Biosimilar Products
09/09/2014- 09/10/2014
Location: Horsham, PA, United States
IACET 13.508.00
Seven-Part Series on Pediatric Drug Development - Part 6: Preclinical Toxicology & Safety
09/09/2014- 09/09/2014
Location: Online
ACPE 1.50, IACET 1.501.00
Art of Writing a Clinical Overview
09/09/2014- 09/11/2014
Location: Online
IACET 6.004.00
Global Considerations for Regulatory Strategy Development
09/15/2014- 09/16/2014
Location: Rockville, MD, United States
IACET 12.508.00
Development of a Clinical Study Report
09/15/2014- 09/15/2014
Location: Rockville, MD, United States
IACET 6.254.00
Strategies for Good Clinical Practice Audits
09/23/2014- 10/02/2014
Location: Online
IACET 7.50, RN 7.504.00
Seven-Part Series on Pediatric Drug Development - Part 7: Operational Challenges of Pediatric Clinical Trials
10/14/2014- 10/14/2014
Location: Online
ACPE 1.50, IACET 1.501.00
Navigating Chemistry, Manufacturing & Controls Through the Drug Development Process
11/03/2014- 11/04/2014
Location: Horsham, PA, United States
IACET 12.758.00