ReconRecon
Recon: Pfizer to increase COVID-19 antiviral output with French deal; Unilever signals pursuit of GSK consumer arm
Posted 17 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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.
Regulatory NewsRegulatory News
Senate committee advances Califf’s nomination as FDA commissioner
Posted 13 January 2022 By Michael Mezher
The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).
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Stakeholders seek clarity on FDA cell and gene therapy draft guidance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Industry, medical societies and other stakeholders have weighed in on draft guidance from the US Food and Drug Administration (FDA) detailing how sponsors that want to study multiple versions of cell and gene therapies could combine them...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
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
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.
Virtual Programs Virtual Programs
Dangerous Documents: Avoiding Land Mines in Your Records and Emails
Thursday, 27 January 2022 (8:00 - 9:30AM) 1.5 RAC Credits Members: $175 | Nonmembers: $200
Learn to analyze and revise written documents to protect yourself and your organization from unwelcome surprises. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
Chapter Events Chapter Events
San Francisco Chapter: IVDs and Diagnostics APAC-Regulatory Hot Topics Round-up Part I
Monday, 31 January 2022 (5:00 - 6:00PM) 1.0 RAC Credits Member: $0 |Nonmember: $25
Learn about In Vitro Diagnostics (IVDs) and Diagnostics APAC-Regulatory hot topics
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.
Chapter Events Chapter Events
Ontario Chapter Webcast: Legislative, Regulatory & Municipal Monitoring using Gnowit
Friday, 04 February 2022 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $25
Insights on monitoring policy updates in Canada using Artificial Intelligence & Machine Learning technologies.
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 08 February 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 |Non-members: $1,150
Designed specifically for those preparing to take the RAC Drugs exam, workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Thursday, 10 February 2022 (8:00 - 9:30AM) 1.5 RAC Credits Members: $150 | Non-members: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
     
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On-demand On-demand
Sponsored Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
1.0 RAC Credits
Member: $0 NonMember: $20
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.
On-demand On-demand
Meet the Authors: Orphan Drug Development for Rare Diseases
1.0 RAC Credits
Member: $0 NonMember: $20
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.
On-demand On-demand
Best Practices on MDR Transition Under Current Conditions (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $20
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
E-books E-books
Quality Management Systems for Drugs and Devices
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
On-demand On-demand
FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
On-demand On-demand
Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $20
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.
On-demand On-demand
Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices
1.0 RAC Credits
Member: $0 NonMember: $20
Four authors from the latest RAPS book, Global Pediatric Development of Drugs, Biologics, and Medical Devices, will be on hand to answer all your burning questions on global pediatric development in regulatory affairs.

All Results

On-demand On-demand

Sponsored Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability

1.0RAC Credits
Member: $0 NonMember: $20
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.
On-demand On-demand

Meet the Authors: Orphan Drug Development for Rare Diseases

1.0RAC Credits
Member: $0 NonMember: $20
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.
On-demand On-demand

Best Practices on MDR Transition Under Current Conditions (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $20
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
E-books E-books

Quality Management Systems for Drugs and Devices

Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
On-demand On-demand

FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
On-demand On-demand

Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $20
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
On-demand On-demand

IVDR 2022: What IVD manufacturers can learn from the MDR rollout

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.
On-demand On-demand

Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices

1.0RAC Credits
Member: $0 NonMember: $20
Four authors from the latest RAPS book, Global Pediatric Development of Drugs, Biologics, and Medical Devices, will be on hand to answer all your burning questions on global pediatric development in regulatory affairs.
On-demand On-demand

Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

1.0RAC 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

Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)

6.0RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.