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...
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...
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...
Regulatory NewsRegulatory News
PFDD: Draft guidance seeks to demystify clinical outcomes assessments
Posted 30 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs).
Regulatory NewsRegulatory News
ICMRA explores hybrid inspections, postapproval changes with new pilots
Posted 29 June 2022 By Joanne S. Eglovitch
A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.  
Regulatory NewsRegulatory News
CAR T cell product development guidance: Comments ask for CMC details
Posted 29 June 2022 By Mary Ellen Schneider
Both industry and clinicians asked the US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.
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The US Food and Drug Administration (FDA) last week issued draft guidance spelling out its expectations for the types of clinical pharmacology assessments that should be conducted during the development of oligonucleotide therapies.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 ...
This Week at FDAThis Week at FDA
This Week at FDA: Spring regulatory agenda, upcoming guidances, and more
Posted 24 June 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. This week, we get a glimpse at FDA’s Spring regu...
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Software as a Medical Device
Tuesday, 18 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 Regulatory Update
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: 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.
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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.
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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.
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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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Learn to Comply With China's UDI Submissions Requirements
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Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.
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Regulatory Intelligence 101, Third Edition
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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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Understanding and Applying FDA’s 510(k) Modifications Guidance
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This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
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Purity is a Virtue: A Practical Guide to the Reporting of Impurities
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Increase your understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take-away messages.
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Complete WHO Guidance Documentation Bundle
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A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
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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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