RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

TrackersTrackers
COVID-19 vaccine tracker
Posted 27 May 2022 By Jeff Craven
Updated 06 May with new information on vaccines from Pfizer/BioNTech, Moderna, Bharat Biotech, Zydus Cadila, Novavax, Medicago and Valneva.
Regulatory NewsRegulatory News
FDA officials reflect on quality maturity model, quality metrics
Posted 27 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said an agency official, the results of which will help inform the d...
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: Upcoming VRBPAC meetings, Califf on the Hill and ARPA-H gets official
Posted 27 May 2022 By Michael Mezher, Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, FDA announced the dates for three upco...
Regulatory NewsRegulatory News
IVDR implementation day overshadowed by lack of notified bodies, risks to patients
Posted 26 May 2022 By Ferdous Al-Faruque
While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not going to be easy, especially due to the lack of notified body capacity to handle t...
Regulatory NewsRegulatory News
Euro Convergence: SSCP expert lists common mistakes device manufacturers make
Posted 26 May 2022 By Ferdous Al-Faruque
AMSTERDAM – Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but such issues tend to be persistent, said Rachel Gibbs, principal r...
RoundupsRoundups
Euro Roundup: EMA moves to suspend 100 generic drugs over ‘flawed studies’ run by Indian CRO
Posted 26 May 2022 By Nick Paul Taylor
The European Medicines Agency (EMA) is set to suspend around 100 generic medicines that came to market based on data from “flawed” bioequivalence studies run by the contract research organization (CRO) Synchron Research Services.
ReconRecon
Recon: Lawmakers grill Califf on response to infant formula crisis; Supply chain, China lockdowns cloud Medtronic’s outlook
Posted 26 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In-Person In-Person
Cybersecurity Unauthorized
Monday, 27 June 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
In-Person In-Person
The Evolving Global UDI Requirements
Wednesday, 29 June 2022 (9:00 - 4:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will cover global UDI requirements and their impact on device manufacturers.
In-Person In-Person
Survivor: The FDA 510(k) Program Edition
Monday, 27 June 2022 (9:00 - 4:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, you will gain an understanding of the 510(k) program and strategies to help obtain a positive clearance decision.
Virtual Programs Virtual Programs
Sponsored Webcast: Audits and Inspections: How to Drive a Standardization Strategy that Sticks
Wednesday, 22 June 2022 (2:00 - 3:00PM) 1.0 RAC Credits Price: Free
Attend this free webcast to learn how implementing standardized and consistent methods can reduce your risk, strengthen your processes and develop robust, repeatable quality.
Chapter Events Chapter Events
Colorado Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships
Thursday, 23 June 2022 (4:00 - 5:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
Chapter Events Chapter Events
NY/NJ Chapter Webcast: Panel Discussion on Leadership Journeys: Navigating Career Paths in Regulatory Affairs
Tuesday, 07 June 2022 (12:00 - 1:30PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join us for a panel discussion by six Women Leaders who have navigated and overcome barriers to chart paths for themselves and others in RA.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | Nonmember: $1,150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  •  
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Laboratory Practice (GLP) [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of GLP regulations as they are applied and interpreted by the FDA, EPA and the Organization for Economic Cooperation and Development.
On-demand On-demand
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
On-demand On-demand
Efficiency and Technology Pave the Way for the New Age of Narrative Writing
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.
Books Books
Risk Management Principles for Devices and Pharmaceuticals
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Generic Drugs in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of the legal and regulatory structure of generic drugs in the US.
On-demand On-demand
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
1.5 RAC Credits
Member: $0 NonMember: $25
This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
Books Books
From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
Books Books
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.

All Results

Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: Advertising and Promotional Labeling in the US [4.0 RAC]

4.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.
Books Books

Promotion of FDA-Regulated Medical Products

Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
On-demand On-demand

US Regulation of Advertising and Promotion of Drugs

6.0RAC 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