Regulatory NewsRegulatory News
European Parliament endorses legislation bolstering EU’s ability to tackle shortages
Posted 20 January 2022 By Joanne S. Eglovitch
The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.
ReconRecon
Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list
Posted 20 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA offers examples of innovative study designs accepted into CID pilot
Posted 20 January 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex Innovative Trial Designs (CID) pilot meet...
RoundupsRoundups
Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation
Posted 20 January 2022 By Nick Paul Taylor
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove u...
RoundupsRoundups
FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq
Posted 19 January 2022 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
ReconRecon
Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer arm
Posted 19 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA extends temporary halt in inspections driven by omicron
Posted 19 January 2022 By Michael Mezher
The US Food and Drug Administration (FDA) has extended its temporary pause on non-mission-critical domestic surveillance inspections through 4 February 2022, an agency spokesperson told Focus on Wednesday.
Regulatory NewsRegulatory News
Califf, experts eye legislative fix for accelerated approval program
Posted 19 January 2022 By Mary Ellen Schneider
Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might b...
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.
Virtual Programs Virtual Programs
Europe Europe
RA Considerations During Clinical Development in the EU
Thursday, 17 February 2022 (8:30 - 4:00PM) 6.0 RAC Credits Members: € 555 | Nonmembers: € 650
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
US Regulatory Essentials, Pharmaceuticals
Monday, 28 February 2022 (9:00 - 5:30PM) 6.0 RAC Credits Member: $495 |Nonmember: $580
An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is for new -intermediate level professionals and those preparing for the RAC Drugs exam
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.
In-Person In-Person
Europe Europe
RAPS Euro Convergence 2022
Tuesday, 10 May 2022 (9:00 - 8:00PM) 12.0 RAC Credits Members: € 1085 | Non-members: € 1290
Join regulatory peers from the EU and globally for RAPS Euro Convergence 2022, 10 – 12 May 2022. This year’s conference will be in person in Amsterdam, Netherlands.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 08 December 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Non-member: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
     
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On-demand On-demand
Meet the Authors, Regulatory Intelligence 101, Third Edition
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The three leading authors will answer your questions on why this book needed to be revised and why all regulatory intelligence (RI) professional can benefit from this update.
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Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets
1.0 RAC Credits
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Join us for a regulatory professional’s presentation on Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets.
Books Books
Choosing the Right Regulatory Career
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Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
Books Books
Regulatory Intelligence 101, Third Edition
Member: $130.00 Nonmember: $180.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
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The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment
1.0 RAC Credits
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This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.
Books Books
Global Medical Device Regulatory Strategy, Second Edition
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Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
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Giving Voice to Regulatory Leadership
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the professional development skills you need for success.
Books Books
International Regulatory Acronyms & Definitions, Third Edition
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International regulatory terms, definitions, and acronyms that will help you develop a better understanding of international regulations.