Regulatory NewsRegulatory News
Califf previews priorities if confirmed as FDA commissioner
Posted 18 January 2022 By Michael Mezher
In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better p...
ReconRecon
Recon: Evotec, Lilly team up on metabolic diseases; Gilead says counterfeiters sold $250M of spurious HIV drugs
Posted 18 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
EU launches clinical trials transformation initiative
Posted 18 January 2022 By Joanne S. Eglovitch
The EU has just kicked off a new initiative meant to transform how clinical trials are initiated and run to promote clinical research in the region. The initiative is meant to address “a relative absence of EU impactful multi-state trial...
RoundupsRoundups
Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests
Posted 18 January 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance...
Regulatory NewsRegulatory News
Former commissioners, Woodcock dissect pandemic response, future challenges at FDA
Posted 17 January 2022 By Joanne S. Eglovitch
A panel of former US Food and Drug Administration (FDA) commissioners, moderated by Acting FDA Commissioner Janet Woodcock, addressed the agency’s role in addressing the current and future pandemics, as well as their predictions for FDA’...
Regulatory NewsRegulatory News
GAO tasks FDA with developing agency-wide workforce plan for medical product staff
Posted 17 January 2022 By Jeff Craven
Centers within the US Food and Drug Administration (FDA) are using the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff, but the agency does not have a wo...
ReconRecon
Recon: Pfizer to increase COVID-19 antiviral output with French deal; Unilever signals pursuit of GSK consumer arm
Posted 17 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDA: User fee update, Califf nomination, and more
Posted 14 January 2022 By Michael Mezher
Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transm...
Virtual Programs Virtual Programs
Digital Health: Fundamentals of FDA Regulation
Friday, 11 February 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $160 | Nonmembers: $175
Examine how FDA regulates digital health including SaMD, AI/ML and cybersecurity, and learn about the implications of the new FDA draft guidance on recommended software documentation for premarket submissions.
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Software as a Medical Device
Tuesday, 25 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 |Nonmember: $1,150
Join regulatory experts to explore evolving global regulatory requirements affecting SaMD, including determining when software is considered regulated as SaMD and how to determine correct class/classification.
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Conflict Resolution and Negotiation: Effective Tools and Techniques (February 2022)
Wednesday, 23 February 2022 (8:00 - 10:00AM) 2.0 RAC Credits Member: $230| Nonmember: $270
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
*Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
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Conflict Resolution and Negotiation: Effective Tools and Techniques (June 2022)
Friday, 03 June 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $195 | Nonmember: $230
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Virtual Programs Virtual Programs
Conflict Resolution and Negotiation: Effective Tools and Techniques (November2022)
Friday, 04 November 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $195 | Nonmember: $230
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Thursday, 10 February 2022 (8:00 - 9:30AM) 1.5 RAC Credits Members: $150 | Non-members: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Friday, 20 May 2022 (1:00 - 3:00PM) 1.5 RAC Credits Member: $150 | Nonmember: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action.
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Friday, 21 October 2022 (8:00 - 9:30AM) 1.5 RAC Credits Member: $150 Nonmember: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action.
     
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On-demand On-demand
CMC - An Integral Component of Cell and Gene Therapy Development
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the US and Canada [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada.
On-demand On-demand
Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $20
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
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
Product Bundle Product Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Books Books
Software as a Medical Device
Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Canadian Regulations [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.
On-demand On-demand
FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
1.0 RAC 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.