The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Regulatory NewsRegulatory News
ICH recaps progress made over past year, charts new topics
Posted 29 November 2021 By Joanne S. Eglovitch
The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the ...
Regulatory NewsRegulatory News
FDA offers draft guidance for registries as RWD
Posted 29 November 2021 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) released draft guidance on the use of registries in regulatory decision making, adding another piece to the puzzle of how the agency will consider real-world data (RWD) when considering a new dru...
Feature ArticlesFeature Articles
The RACE is on: Opportunities in pediatric oncology product development
Posted 19 November 2021 By Lisa Crose, PhD, RAC
Pediatric oncology patients continue to have significant unmet medical need. Although the Pediatric Research Equity Act (PREA) mandated evaluation of new drugs for pediatric patients, the rarity and uniquity of pediatric cancers allowed ...
Regulatory NewsRegulatory News
Biden nominates Califf as FDA commissioner
Posted 12 November 2021 By Michael Mezher
After months of speculation – and just days before a statutory deadline – President Joe Biden on Friday announced he would nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time.
RoundupsRoundups
Approvals Roundup: Xipere, Seglentis, Dupixent
Posted 27 October 2021 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
RoundupsRoundups
FDA Approvals Roundup: Tavneos, Verzenio, Dextenza
Posted 13 October 2021 By Renee Matthews, Kari Oakes
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
Feature ArticlesFeature Articles
Strategies for managing regulatory risk with third-party distributors
Posted 30 September 2021 By Maham Ansari, MS, RAC
In today’s global healthcare distribution market, an increasing number of medical device and in vitro diagnostic medical device (IVD) companies are aspiring to market globally. One of the main challenges these manufacturers face is how t...
Regulatory NewsRegulatory News
Pharmaceutical industry signals support for FDA’s BsUFA III commitment letter
Posted 29 September 2021 By Joanne S. Eglovitch
Two major pharmaceutical industry groups have endorsed the US Food and Drug Administration’s (FDA’s) recent commitment letter under its Biosimilar User Fee Amendments (BsUFA III) program which will run from FY 2023 to 2027, calling it an...
Virtual Programs Virtual Programs
Business Writing for Regulatory Professionals
Thursday, 10 March 2022 (8:00 - 9:30AM) 1.5 RAC Credits Member: $150 Nonmember: $175
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise. *Global Time Zones* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
Virtual Programs Virtual Programs
Business Writing for Regulatory Professionals
Friday, 17 June 2022 (6:00 - 7:30AM) 1.5 RAC Credits Member: $150 Nonmember: $175
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise. *Global Time Zones* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
Virtual Programs Virtual Programs
Business Writing in Regulatory Settings
Friday, 18 November 2022 (1:00 - 2:30PM) 1.5 RAC Credits Member: $150 Nonmember: $175
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise. *Global Time Zones* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Tuesday, 14 December 2021 (9:00 - 4:00PM) 12.0 RAC Credits Member: $800 Nonmember: $900
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 20 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Receive an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in the US, Europe, and other regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in US, Europe, and other regulated regions
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
     
  •  
  • 1
  •  
  • 2
  •  
  •  
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the US and Canada [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada.
Books Books
The European In Vitro Diagnostic Regulation (Paperback)
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
On-demand On-demand
Giving Voice to Regulatory Leadership
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the professional development skills you need for success.
Books Books
Introduction to the Due Diligence Process, Second Edition (Paperback)
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand
Achieving 21 CFR 11 Compliance with Cloud-Deployed Systems
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
We'll describe the challenges faced by small FDA-regulated companies in managing and controlling the content of eTMF, eCTD and QMS.
On-demand On-demand
US Regulation of Advertising and Promotion of Drugs
6.0 RAC Credits
Member: $399.00 Nonmember: $499.00
Examine the current requirements for advertising and promotion of healthcare products in the US, and how they impact the way you communication with healthcare professionals, consumers and managed care audiences
On-demand On-demand
Most Common Findings in EU Clinical Evaluations
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the most common findings identified by Notified Bodies and by Qserve when performing a final CER review to the requirements of the MDR and MEDDEV 2.7/1 rev.4.
On-demand On-demand
Effective Labeling Management Requires a New Mindset : A Strategic Guide to Labeling Process Optimization
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the best methods to evaluate factors that could affect product labeling management.
     
  •  
  • 1
  •  
  • 2
  •  
  •