Regulatory NewsRegulatory News
VRBPAC recommends addition of Omicron-component to future boosters
Posted 28 June 2022 By Ferdous Al-Faruque
A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an...
ReconRecon
Recon: EU approves two Sanofi treatments for rare diseases; Novartis to cut 8,000 staffers as part of global reorganization
Posted 28 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA proposes rule broadening nonprescription drug access for consumers
Posted 28 June 2022 By Jeff Craven
The US Food and Drug Administration (FDA) has issued a new proposed rule that would allow drug companies to add conditions for consumers to access nonprescription drug products.
RoundupsRoundups
Asia-Pacific Roundup: TGA adds chapters on SaMD, personalized devices to clinical evidence guidelines
Posted 28 June 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, adding new chapters on software as a medical device (SaMD) and personalized medical devices (PMDs), prompted by regulato...
Regulatory NewsRegulatory News
FDA official: Virtual audits, records requests may be sticking around
Posted 27 June 2022 By Joanne S. Eglovitch
CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite...
Regulatory NewsRegulatory News
Oligonucleotides: FDA drafts clinical pharmacology guidance
Posted 27 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) last week issued draft guidance spelling out its expectations for the types of clinical pharmacology assessments that should be conducted during the development of oligonucleotide therapies. The ...
Regulatory NewsRegulatory News
FDA finalizes guidance on food effect studies, issues draft on contamination prevention for non-penicillin beta-lactam drugs
Posted 27 June 2022 By Jeff Craven
The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (ND...
ReconRecon
Recon: FDA signals support for updated COVID vaccines; EMA recommends BioMarin’s hemophilia gene therapy
Posted 27 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In-Person In-Person
Software as a Medical Device
Wednesday, 29 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 review current and evolving regulatory requirements for software as a medical device to navigate the challenging expectations for software products
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’s Proposed Rule Revamps the Quality System Regulation (21 CFR 820) – Are you Ready?
Wednesday, 03 August 2022 (9:00 - 10:00AM) 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 (10:00 - 2:00PM) 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.
     
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On-demand On-demand
Sponsored Webcast: FDA’s Proposed Rule Revamps the Quality System Regulation (21 CFR 820) – Are you Ready? (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Speakers 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.
On-demand On-demand
Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
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.
Books Books
Fundamentals of Medical Device Regulations, Fifth Edition
Member: $295.00 Nonmember: $395.00
A current view of regulations governing medical devices and IVDs, and covers the entire medical device lifecycle, from product development through postmarketing.
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 webcast 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.
On-demand On-demand
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.

All Results

On-demand On-demand

Strategies for Successful PMCF Planning and Execution

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Walks you through a clear process for ensuring your PMCF planning is effective and efficient, beginning with an overview of what's required and how to evaluate your current state against the requirements.
On-demand On-demand

Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies

1.0RAC 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.
On-demand On-demand

Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges - both past and future - related to EU MDR.
On-demand On-demand

How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers

1.0RAC 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.
Books Books

The European In Vitro Diagnostic Regulation

Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Books Books

Introduction to the Due Diligence Process, Second Edition

Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand

How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade

1.0RAC 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

Fundamentals of EU Regulatory Affairs, Ninth Edition

Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
On-demand On-demand

Update Your Medical Device UDI Data and Labels: This Year FDA Class I / Next Year EU MDR

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Join speakers from Reed Tech Life Sciences and NiceLabel for an interactive webcast focused on two compliance areas they are monitoring closely.
On-demand On-demand

Are You Ready to Begin Planning your IND Submission?

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.