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.
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.
TrackersTrackers
COVID-19 vaccine tracker
Posted 14 January 2022 By Jeff Craven
Updated 14 January to include new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Sinopharm, CanSino Biologics, Bharat Biotech/Ocugen, Center for Genetic Engin...
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Recon: Biogen wants dialogue with CMS over Aduhelm coverage decision; GSK, Vir seek authorization for COVID antibody shot
Posted 13 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: CMS to restrict coverage of Aduhelm to only clinical trials; FDA warns of dental issues with buprenorphine
Posted 12 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Recon: Pfizer to cut sales staff as provider meetings move virtual; US buys 600k more doses of GSK-Vir COVID therapy
Posted 11 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Recon: Bristol Myers buoys cell therapy interests with $3B Century deal; EMA could issue decision on Paxlovid within weeks
Posted 10 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDA: Senate committee to vote on Califf’s nomination; FDA ordered to speed release of Pfizer vaccine documents
Posted 07 January 2022 By Michael Mezher
Welcome back to This Week at FDA! There’s lots of big news to cover in this week’s installment, including some items from before the holidays, updates on COVID-19 vaccines and Robert Califf’s nomination to lead the FDA. Plus, we get word...
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.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Medical Devices
Member: $1230 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Pharmaceuticals, you can complete the two remaining core courses of the Dual Certificate and three additional electives.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.
Books Books
Risk Management Principles for Devices and Pharmaceuticals
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
Online Course Online Course
Dual Certificate Dual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,590.00 Nonmember: $4,490.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Books Books
Complete WHO Guidance Documentation Bundle
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1230.00 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.
     
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