Regulatory NewsRegulatory News
Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants
Posted 06 July 2022 By Jeff Craven
Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Admi...
Regulatory NewsRegulatory News
European Commission adopts common specifications for high-risk IVDs
Posted 06 July 2022 By Michael Mezher
The European Commission on Monday issued a regulation that establishes common specifications certain high-risk in vitro diagnostics (IVD), which are a critical component of the In Vitro Diagnostic Regulation (IVDR).
Regulatory NewsRegulatory News
Health policy experts call for stronger accelerated approval reforms
Posted 06 July 2022 By Mary Ellen Schneider
The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority around accelerated approvals, including the power to expedite the withdrawal of drugs from the market, acc...
ReconRecon
Recon: FDA grants priority review for Biogen-Eisai’s Alzheimer’s drug; Senate Democrats advance drug-price deal
Posted 06 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA publishes two critical DSCSA draft guidances
Posted 05 July 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the ph...
ReconRecon
Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition
Posted 05 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Asia-Pacific Roundup: TGA updates uniform recall procedure
Posted 05 July 2022 By Nick Paul Taylor
Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the ...
This Week at FDAThis Week at FDA
This Week at FDA: User fee timeline, bivalent boosters, and more
Posted 01 July 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. The biggest news out of FDA this week was the ag...
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.
Chapter Events Chapter Events
Ontario Chapter Webcast: What, Why and When of Postmarket Clinical Follow-up
Thursday, 21 July 2022 (12:00 - 1:00PM) 1.0 RAC Credits PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.
Virtual Programs Virtual Programs
Root Cause Investigation for CAPA
Tuesday, 26 July 2022 (11:00 - 3:00PM) 12.0 RAC Credits Member: $970| Nonmember: $1150
Investigative tools used to identify technical root causes, systemic root causes, corrective and preventive actions, and control plans to monitor and prevent recurrence.
Chapter Events Chapter Events
Indiana Chapter Webcast: Challenges and Lessons Learned from Both an Industry and Notified Body Perspective for the Implementation of EU Regulations
Tuesday, 26 July 2022 (3:30 - 5:00PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join regulatory professionals for an overview of key learnings obtained on the journey to MDR and IVDR certification.
Virtual Programs Virtual Programs
Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
Wednesday, 03 August 2022 (10:00 - 11:00AM) 1.0 RAC Credits Member: $0 | NonMember: $0
In this webcast, experts will review the history of quality systems, look at the changes to quality regulations, and discuss the FDA’s intent to adopt the ISO 13485 standard.
Virtual Programs Virtual Programs
Tackling the CMC Challenges for Cell and Gene Therapy Product Development
Wednesday, 03 August 2022 (12:00 - 2:00PM) 2.0 RAC Credits Price: Member: $195 / Nonmember $230
Key opinion leaders from academia, industry, and a regulatory agency will discuss these strategies in addressing CGT manufacturing challenges to bring transformative medicines to patients.
Virtual Programs Virtual Programs
Setting the Standard for Real-World Evidence: Research Methods and Data Quality for Medical Devices
Friday, 05 August 2022 (12:00 - 1:30PM) 6.0 RAC Credits Member: $150 NonMember: $175
Key principles and considerations in designing and executing a real-world evidence study for medical-device evaluation will be outlined.
Virtual Programs Virtual Programs
US Regulation of Advertising and Promotion for Drugs and Biologics (2022)
Thursday, 11 August 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 | Nonmembers: $680
Examine requirements, guidelines, and expectations for advertising and promotion of pharmaceuticals in the US.
     
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On-demand On-demand
Sponsored Webcast: The Next Generation of Postmarket Medical Device Surveillance
1.0 RAC Credits
Member: $0 NonMember: $25
Panelists will discuss postmarket medical device surveillance including the Active Surveillance Task Force, Common Data Model, and the Active Surveillance Cloud Infrastructure from a variety of perspectives.
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Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)
1.5 RAC Credits
Member: $0 NonMember: $25
Learn to leverage electronic QMS systems to build compliance. This live broadcast will debunk QMS myths and address the challenges in ensuring data integrity.
On-demand On-demand
2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
This webcast will show how manufacturers can expedite the path to market for new China NMPA submissions. It will cover Order 739, when to file for modifications, how to keep medical devices compliant, and more.
Books Books
Regulation of Regenerative Medicines: A Global Perspective
Member: $145.00 Nonmember: $200.00
Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.
On-demand On-demand
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
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Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Simplify UDI complexity by exploring requirements across several major markets, including the types of devices that are covered and the expected implementation timelines.
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COVID-19 EUAs: The Beginning of the End
1.5 RAC Credits
Member: $0 NonMember: $25
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.
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Sponsored Webcast: Early Clinical, CMC, and Device Development Considerations Unique to Cellular and Gene Therapy Products (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webcast will cover the development and regulatory process for new therapeutics, proven strategies that help reduce risk of failure, and how to streamline clinical development and increase speed to market.

All Results

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Meet the Authors: Orphan Drug Development for Rare Diseases

1.0RAC 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.
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Best Practices on MDR Transition Under Current Conditions (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
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 (e-book)

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

1.0RAC Credits
Member: $0 NonMember: $25
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.
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Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices

1.0RAC Credits
Member: $0 NonMember: $25
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.
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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.
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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.
Books Books

Global Pediatric Development of Drugs, Biologics, and Medical Devices

Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.