Regulatory NewsRegulatory News
FDA blasts California firm for multiple GLP issues involving nonclinical studies
Posted 11 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinical studies at West Sacramento, CA firm Valley Biosystems in a 3 August warning letter and blasted the fi...
Regulatory NewsRegulatory News
FDA Official: EU privacy regulations impede BIMO inspections, application reviews
Posted 10 August 2022 By Ferdous Al-Faruque
According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General...
Regulatory NewsRegulatory News
FDA issues Jynneos EUA to stretch monkeypox vaccine supply
Posted 09 August 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Bavarian Nordics’ monkeypox vaccine Jynneos to be administered to adults intradermally. The move is meant to significantly increase the availabili...
Regulatory NewsRegulatory News
Drugmakers request changes to FDA’s mass balance studies guidance
Posted 09 August 2022 By Joanne S. Eglovitch
The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mass balance studies, suggesting the guidance be revised to require fewer subjects, and mention a male prefe...
Regulatory NewsRegulatory News
Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation
Posted 09 August 2022 By Ferdous Al-Faruque
When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling eff...
Regulatory NewsRegulatory News
Manufacturers that are not testing DSCSA data systems now are in 'big trouble'
Posted 08 August 2022 By Joanne S. Eglovitch
While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these syst...
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: EtO, user fee woes, and product specific guidances
Posted 05 August 2022 By Ferdous Al-Faruque
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. This week the Environmental Protection Agency (EP...
Regulatory NewsRegulatory News
EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end
Posted 03 August 2022 By Ferdous Al-Faruque
The US Environmental Protection Agency (EPA) has published a list of ethylene oxide (EtO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. The agency also plans to publish a...
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Software as a Medical Device
Thursday, 20 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1,080 | Nonmembers: € 1,265
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
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Effectively Coping with the European IVD Regulation
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1080 | Nonmembers: € 1,264
Although much is clear in the IVD-R text, as the saying goes "the devil is in the details" and there are lots of areas still open to interpretation and which need further guidance.
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Cybersecurity
Thursday, 20 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: €1080 | Nonmembers: €1265
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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China Drug Market Opening Up for Foreign Drug Makers
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
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Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions
Wednesday, 05 October 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
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Meet the Authors, Regulatory Writing, Second Edition
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Hear from the experts who wrote the book on regulatory writing. Authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will discuss the new edition’s writers-eye view of regulatory documentation.
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Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities
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Industry-leading regulatory experts will provide practical insights on how to assess RI needs, why this area is worth the investment, and how to build an RI strategy that fortifies the unique objectives of your company.
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EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe
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The presenters will outline essential information and considerations for device manufacturers across the EU and explain everything you need to do to remain compliant.
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Regulatory Intelligence and Its Value in Regulated Industry
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The fundamentals of global regulatory intelligence, and how it can be used to influence regulatory decision making throughout a development program and lifecycle management of a therapeutic product.
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2020 NMPA (CFDA) Key Updates and Look Ahead on 2021
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How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal, and to know when to file for modifications to avoid penalties?
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Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions (On-Demand)
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This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
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China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739
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Review the key highlights of this new policy and the implications for overseas companies in premarket submission clinical and technical requirements, innovation focus, MAH and post market changes.
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Global Regulatory Strategy for Pharmaceuticals [4.0 RAC]
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This course provides a basic understanding of the challenges and goals confronting a regulatory professional when defining a global regulatory strategy.
     
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FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)

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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.