RoundupsRoundups
Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests
Posted 18 January 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance...
Regulatory NewsRegulatory News
GAO tasks FDA with developing agency-wide workforce plan for medical product staff
Posted 17 January 2022 By Jeff Craven
Centers within the US Food and Drug Administration (FDA) are using the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff, but the agency does not have a wo...
Regulatory NewsRegulatory News
This Week at FDA: User fee update, Califf nomination, and more
Posted 14 January 2022 By Michael Mezher
Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transm...
TrackersTrackers
COVID-19 vaccine tracker
Posted 14 January 2022 By Jeff Craven
Updated 14 January to include new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Sinopharm, CanSino Biologics, Bharat Biotech/Ocugen, Center for Genetic Engin...
Regulatory NewsRegulatory News
WHO charts path to convergence on cell and gene therapies
Posted 14 January 2022 By Joanne S. Eglovitch
The World Health Organization (WHO) has issued a white paper for consultation that proposes a risk-based framework for regulating cell and gene therapy products (CGTPs) to promote global convergence among health authorities.
ReconRecon
Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot
Posted 13 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Stakeholders seek clarity on FDA cell and gene therapy draft guidance
Posted 13 January 2022 By Jeff Craven
Industry, medical societies and other stakeholders have weighed in on draft guidance from the US Food and Drug Administration (FDA) detailing how sponsors that want to study multiple versions of cell and gene therapies could combine them...
RoundupsRoundups
Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback
Posted 13 January 2022 By Nick Paul Taylor
The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.
Virtual Programs Virtual Programs
US Regulatory Essentials, Devices
Tuesday, 22 March 2022 (10:00 - 3:30PM) 12.0 RAC Credits Members: $825| Nonmembers: $970
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.
Europe Europe
Virtual Programs Virtual Programs
Rollout IVDR 2022: How to prepare for the IVDR by May 2022. Date of Application or Dead on Arrival?
Wednesday, 23 March 2022 (1:00 - 5:00PM) 6.0 RAC Credits Member: € 710 | Nonmember: € 835
Learn which aspects to consider when writing a regulatory plan, along with several pathways to speed up development, including PRIME and adaptive pathways.
Virtual Programs Virtual Programs
Digital Health: Fundamentals of FDA Regulation
Friday, 11 February 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $160 | Nonmembers: $175
Examine how FDA regulates digital health including SaMD, AI/ML and cybersecurity, and learn about the implications of the new FDA draft guidance on recommended software documentation for premarket submissions.
Virtual Programs Virtual Programs
Software as a Medical Device
Tuesday, 25 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 |Nonmember: $1,150
Join regulatory experts to explore evolving global regulatory requirements affecting SaMD, including determining when software is considered regulated as SaMD and how to determine correct class/classification.
Chapter Events Chapter Events
Wisconsin Chapter Webcast: Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
Tuesday, 01 February 2022 (2:00 - 3:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $25
Learn new best practices and thinking to software and hardware computing technologies and embrace a more modern approach to device safety.
Virtual Programs Virtual Programs
Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?
Tuesday, 26 April 2022 (9:00 - 2:00PM) 6.0 RAC Credits Member: $495 | Nonmember: $580
This workshop is for the regulatory professional who wants to successfully navigate crucial aspects of human factors and prevent obstacles and risks to your submissions.
Europe Europe
In-Person In-Person
Software as a Medical Device
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1,120
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
Europe Europe
In-Person In-Person
Cybersecurity
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1120
Gain the knowledge you need to navigate global cybersecurity expectations, translate regulatory expectations into concrete design and development activities and establish trust with customers.
     
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Books Books
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Combination Products [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides a historical perspective on combination product regulation in the US, and examines the current regulations and policies covering the identification, jurisdiction and review of combination product
On-demand On-demand
How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The webcast features lessons learned from the COVID-19 pandemic about leveraging risk management and quality management systems to maximize business success in times of disruption and digital transformation.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the EU [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course focuses on the development of healthcare product regulation in the European Union (EU). It discusses the responsibilities of agencies involved, processes employed and interactions among agencies.
On-demand On-demand
China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.
On-demand On-demand
Sponsored Webcast: Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $0
This webcast will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid pcase reports of manufacturers moving through the transitioning to applying the EU MD
RAC Prep RAC Prep
RAC (Devices) Practice Test
Member: $85.00 Nonmember: $105.00
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Supplier Management [3.0 RAC]
6.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety.