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
Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
Tuesday, 17 May 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $0 | Nonmembers: $0
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.
Virtual Programs Virtual Programs
3rd Party Servicing: Underreported, Understudied, and Underregulated
Wednesday, 18 May 2022 (1:00 - 2:30PM) 1.5 RAC Credits Pricing: $0
Learn the difference between servicing and re-manufacturing a medical device, the regulatory requirements for each, concerns with unregulated 3rd party servicing activities and potential solutions to the problem.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970|Nonmember: $1,150
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 region
Virtual Programs Virtual Programs
Sponsored Webcast: Smarter Clinical Document Automation for Transparency and Disclosure Requirements
Thursday, 19 May 2022 (11:00 - 12:00PM) 1.0 RAC Credits Price: $0
This program will cover the transparency initiative surrounding clinical documentation and medical writing and will explain the process for meeting those requirements using patient narratives as a case study.
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Friday, 20 May 2022 (1:00 - 2:30PM) 1.5 RAC Credits Member: $150 | Nonmember: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action.
In-Person In-Person
Executive Development Program at the Kellogg School of Management
Sunday, 22 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
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.
Virtual Programs Virtual Programs
Ensure Your MDR Program is State of the Art
Tuesday, 24 May 2022 (12:00 - 1:30PM) 1.5 RAC Credits Price: $0
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  • 5
  •  
  • 6
  •  
  •  
Product Bundle Product Bundle
GxP Bundle
Member: $865.00 Nonmember: $1,292.00
This three-course series examines essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
On-demand On-demand
Purity is a Virtue: A Practical Guide to the Reporting of Impurities
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Increase your understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take-away messages.
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
Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships (On-Demand)
Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
On-demand On-demand
Ensure Your MDR Program is State of the Art (On-Demand)
1.5 RAC Credits
Member:$0 NonMember:$25
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
On-demand On-demand
Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
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
Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective
1.0 RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.