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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)
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
Development of a Clinical Study Report
03/13/2014- 12/31/2015
Location: Online
None Available4.00
The Future of Personalized Medicine and Companion Diagnostics
03/20/2014- 03/31/2015
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
Designed for Success: Utilizing Protocol Quality by Design (QbD) to Plan Clinical Studies
05/01/2014- 04/30/2015
Location: Online
None Available1.00
How to Prepare for a Safety Inspection
05/08/2014- 06/05/2015
Location: Online
None Available3.00
Generic Drug Labeling Proposed Rule and Safety Updates
05/16/2014- 05/31/2015
Location: Online
None Available1.00
Pharmacovigilance and Risk Management: Patient Perspective
05/22/2014- 05/21/2015
Location: Online
None Available1.00
Supplements and Other Changes to an Approved Application
06/10/2014- 06/09/2015
Location: Online
None Available1.00
Seven-Part Series on Pediatric Drug Development - Part 3: Regulatory Framework EU
06/18/2014- 10/13/2015
Location: Online
None Available1.00
Variations in the European Union: CMC/Quality Changes
06/26/2014- 06/30/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 1: Fundamentals of Clinical Pharmacology: Pharmacokinetics
07/10/2014- 11/05/2015
Location: Online
None Available1.00
Seven-Part Pediatric Drug Development Webinar Series - Part 4: Dosing in Children
07/15/2014- 10/13/2015
Location: Online
None Available1.00
Seven-Part Series on Pediatric Drug Development - Part 2: Regulatory Framework US Overview
07/15/2014- 10/13/2015
Location: Online
None Available1.00
Pharmacovigilance and Global Harmonization Updates
07/24/2014- 07/23/2015
Location: Online
None Available1.00
Adverse Event Reporting Requirements: IND and Postmarketing
07/24/2014- 06/30/2015
Location: Online
None Available3.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 2: Fundamentals of Clinical Pharmacology: Pharmacodynamics
08/07/2014- 11/05/2015
Location: Online
None Available1.00
Seven-Part Series on Pediatric Drug Development - Part 5: Technical Development: Pediatric Formulations
08/13/2014- 10/13/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology For Drug Development - Part 3: Principles of Modeling and Simulation
09/05/2014- 10/31/2015
Location: Online
None Available1.00
Seven-Part Series on Pediatric Drug Development - Part 6: Preclinical Toxicology & Safety
09/09/2014- 10/13/2015
Location: Online
None Available1.00
Clinical Trials Transparency 3-Part Series: Moving the Debate Forward - Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 1 - Paving the Way for Greater Access To Data
09/09/2014- 02/01/2016
Location: Online
None Available1.00
The Role of the Clinical Data Manager
10/08/2014- 10/07/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 4: Determining the Safe First Human Dose
10/09/2014- 10/31/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 5: Assessment of QT Prolongation
11/06/2014- 11/05/2015
Location: Online
None Available1.00
Implementing Risk-Based Monitoring: Practical Approaches
11/13/2014- 12/08/2015
Location: Online
None Available1.00
Target Product Profile – Strategies to Optimize Drug Development, Product Labeling, and Commercialization
11/05/2014- 12/01/2015
Location: Online
None Available1.00
Implementation and Status of Periodic Benefit-Risk Evaluation Reporting (PBRER) in Canada
11/05/2014- 12/08/2015
Location: Online
None Available1.00
Clinical Trials Transparency 3 Part Webinar Series - Part 3: Understanding the Legislation Landscape: Regulatory Updates from the FDA, EMA and Health Canada
02/11/2015- 02/01/2016
Location: Online
None Available1.00
Art of Writing a Clinical Overview
02/24/2015- 02/26/2016
Location: Online
None Available6.00
Pricing, Economic, Reimbursement, Market Share (PERMS) Strategy: An Interactive Holistic Approach in Rare Diseases
03/05/2015- 03/05/2015
Location: Online
IACET 1.501.00
Pricing, Economic, Reimbursement, Market Share (PERMS) Strategy: An Interactive Holistic Approach in Rare Diseases
03/05/2015- 03/04/2016
Location: Online
None Available1.00
CMC Workshop 2015
04/13/2015- 04/15/2015
Location: Bethesda, MD, United States
ACPE 12.00, IACET 17.2510.00
DIA/FDA Statistics 2015 Forum
04/20/2015- 04/22/2015
Location: North Bethesda, MD, United States
IACET 18.5012.00
Biosimilar Development: Strategies and Regulatory Requirements for Global Market Entry
-
Location:
IACET 13.508.00
Oversight of Clinical Monitoring: Trends and Strategies
05/05/2015- 05/07/2015
Location: Online
IACET 6.003.00
Electronic Submissions: The Next Era of Electronic Submissions
05/14/2015- 05/14/2015
Location: Philadelphia, PA, United States
IACET 6.504.00
How to Prepare for a Safety Inspection
06/01/2015- 06/03/2015
Location: Online
IACET 6.004.00
DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.
-
Location:
CME 18.00, RN 18.0012.00
#20: The Sunshine Act: Understanding the Essentials of Compliance
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 3.25, IACET 3.25, RN 3.252.00
#23: How to Prepare for an FDA Inspection
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 3.25, IACET 3.25, RN 3.252.00
#24: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 3.25, 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
06/14/2015- 06/14/2015
Location: Washington, DC, United States
IACET 3.252.00
#31: Preparing for a US FDA Advisory Committee Meeting
06/14/2015- 06/14/2015
Location: Washington, DC, United States
IACET 3.252.00
#33: Large-Scale Regulatory Functional Outsourcing: Emerging Trends, Challenges, and Decision Criteria
06/14/2015- 06/14/2015
Location: Washington, DC, United States
IACET 3.252.00
#35: Ethical Issues in Clinical Trials
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 3.25, IACET 3.25, RN 3.252.00
#42: Fundamentals of ANDA Submissions and FDA Expectations Under GDUFA
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 6.50, IACET 6.50, RN 6.504.00
#44: Risk Management and Safety Communication Strategies
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#45: The Good Pharmacovigiliance Practices in the EU: Global Applications
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 6.50, IACET 6.50, RN 6.504.00
Development of a Clinical Study Report
08/10/2015- 08/10/2015
Location: Boston, MA, United States
IACET 6.504.00
Adaptive Design in Clinical Trials: When and How to Apply
09/14/2015- 09/15/2015
Location: Washington, DC, United States
IACET 13.508.00
Navigating Chemistry, Manufacturing and Controls Through the Drug Development Process
11/09/2015- 11/10/2015
Location: Philadelphia, PA, United States
IACET 13.008.00