ReconRecon
Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug
Posted 21 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations
Posted 20 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation
Posted 19 October 2021 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) is set to allow more flexibility in how medical device patient information materials are provided after holding a consultation into possible reforms.
ReconRecon
Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds
Posted 19 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children
Posted 18 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
TrackersTrackers
COVID-19 vaccine tracker
Posted 15 October 2021 By Jeff Craven
Updated 15 October with new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Bharat Biotech, Anhui Zhifei Longcom Biopharmaceutical, CGEB, Finlay Institute of V...
ReconRecon
Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug
Posted 15 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage
Posted 14 October 2021 By Michael Mezher
Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Virtual Programs Virtual Programs
Rollercoaster Ride Ahead: Time Is Short for EU IVDR Transition
Wednesday, 10 November 2021 (10:00 - 3:30PM) 6.0 RAC Credits At this stage, manufacturers must be finalizing their transition plan for applying these new requirements to keep their devices in the EU market. Join this two-day workshop for help in developing a clearer path to your transition plan.
Virtual Programs Virtual Programs
US Regulatory Essentials, Pharmaceuticals
Wednesday, 17 November 2021 (9:00 - 5:30PM) 6.0 RAC Credits An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is tailored for new to intermediate level professionals and those preparing for the RAC Drugs examination.
Virtual Programs Virtual Programs
US Regulatory Essentials, Devices (November 2021)
Thursday, 18 November 2021 (10:00 - 4:00PM) 12.0 RAC Credits This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs. It will cover laws, regulations, FDA guidance, strategies for FDA submissions, advertising and labeling, post-market compliance, and more.
Books Books
Europe Europe
The Medical Device Validation Handbook, Second Edition (Hardcover)
Member: $125.00 Nonmember: $175.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Books Books
Europe Europe
The European Medical Device Regulation (2021 Update) (Paperback)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
On-demand On-demand
Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this webcast aims to share some of those best practices using SARS-CoV-2 as a case study.
Books Books
Europe Europe
The European In Vitro Diagnostic Regulation (Paperback)
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
On-demand On-demand
China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
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.
On-demand On-demand
China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
On-demand On-demand
Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities
1.0 RAC Credits
Member: $0 Nonmember: $20
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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