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.

Regulatory NewsRegulatory News
FDA, EMA officials discuss impediments to cell and gene therapies
Posted 17 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a  “playbook” or platform approach for developing multiple cell and gene therapy products and a globally harmonized template would facilitate the develop...
RoundupsRoundups
Asia-Pacific Roundup: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback
Posted 17 May 2022 By Nick Paul Taylor
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in light of industry feedback on the draft proposal. Medsafe is retaining the proposed 4.2% increase across all fees but making...
ReconRecon
Recon: FDA authorizes Pfizer COVID booster for children 5-11; AstraZeneca strikes $157M licensing deal with RQ Bio
Posted 17 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints
Posted 17 May 2022 By Jeff Craven
More than half of the novel drugs approved by the US Food and Drug Administration (FDA) in 2020 were supported by a single pivotal trial, and slightly less than half of pivotal trials supporting novel drug approval used surrogate endpoin...
Regulatory NewsRegulatory News
FDA works to advance real-world data collection in pregnancy and lactation
Posted 16 May 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety and efficacy of medications used during pregnancy and lactation.
Regulatory NewsRegulatory News
IVDR: Commission adds risk management standard to harmonized standards list
Posted 16 May 2022 By Michael Mezher
The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
ReconRecon
Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA’s RWE pilot cites challenges in emulating RCTs
Posted 16 May 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This Week at FDAThis Week at FDA
Regulatory NewsRegulatory News
This Week at FDA: House holds user fee markup, CDER’s ARC for rare diseases
Posted 13 May 2022 By Michael Mezher
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, we saw legislation to reauthorize the ...
Virtual Programs Virtual Programs
US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2022)
Wednesday, 25 May 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 NonMembers: $680
This virtual program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
Chapter Events Chapter Events
NY/NJ Chapter Webcast- Decision-Making Overview of RWD/RWE Guidances (and RWE Use Successes and Pitfalls)
Monday, 23 May 2022 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
The use of real-world evidence can accelerate drug development and product approvals. However, the acceptable use of real-world evidence for regulatory purposes is a rapidly evolving area where industry.
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
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
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.
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.
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
  •  
  • 5
  •  
  • 6
  •  
  •  
RAC Prep RAC Prep
RAC (Devices) Prep Toolbox
Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.
On-demand On-demand
Meet the Authors: Orphan Drug Development for Rare Diseases
1.0 RAC Credits
Price: $0
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.
Books Books
Regulatory Intelligence 101, Third Edition
Member: $130.00 Nonmember: $180.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
On-demand On-demand
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the application of a modern approach to risk management as a product moves through the product lifecycle.
Books Books
Terms & Definitions of Japanese Regulatory Affairs
Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.
On-demand On-demand
Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
1.0 RAC Credits
Member: $0 NonMember: $25
Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.
On-demand On-demand
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.

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