ReconRecon
Recon: EMA starts rolling review of Pfizer-BioNTech variant vaccine; Pfizer halts Paxlovid study enrollment for lower-risk population
Posted 15 June 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: FDA approves Lilly’s alopecia drug; EU states pressure Pfizer to cut unneeded COVID vaccine supplies
Posted 14 June 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch
Posted 13 June 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Generic drugmakers face narrow win in price-fixing case; German authority recommends Imvanex monkeypox vaccine
Posted 09 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Moderna touts Omicron-targeted bivalent vaccine; EMA lists critical medicines against COVID-19
Posted 08 June 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: FDA gives thumbs-up to GSK measles vaccine; FDA committee set to review Novavax COVID vaccine EUA on Tuesday
Posted 06 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Pfizer to sell its stake in GSK consumer business after London listing; Sage postpartum depression drug hits goals in Phase III
Posted 01 June 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Moderna completes EUA submission for younger kids and adolescents; Generic firms to cap price of Paxlovid copies at $25 in low-income countries
Posted 12 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
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In-Person In-Person
Europe Europe
Regulatory Leadership
Thursday, 20 October 2022 (9:00 - 5:00PM) 0.0 RAC Credits Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
Europe Europe
In-Person In-Person
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.
Europe Europe
In-Person In-Person
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.
Europe Europe
In-Person In-Person
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.
Books Books
The Medical Device Validation Handbook, Second Edition
Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Books Books
The European Medical Device Regulation (2021 Update)
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.
Books Books
The European In Vitro Diagnostic Regulation
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Books Books
Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
Books Books
Fundamentals of EU Regulatory Affairs, Ninth Edition
Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
On-demand On-demand
PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
On-demand On-demand
Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges - both past and future - related to EU MDR.
On-demand On-demand
PMS Requirements of the EU MDR: Implementation Challenges and Solutions
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will go into detail about strategies to overcome audit findings and gaps in your evidence.
     
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All Results

In-Person In-Person
Europe Europe

Regulatory Leadership

Thursday, 20 October 2022 (9:00 - 5:00PM)
Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
Europe Europe
In-Person In-Person

Software as a Medical Device

Tuesday, 18 October 2022 (9:00 - 5:00PM)
12.0RAC 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.
Books Books

The Medical Device Validation Handbook, Second Edition

Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Books Books

The European Medical Device Regulation (2021 Update)

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.
Europe Europe
In-Person In-Person

Effectively Coping with the European IVD Regulation

Tuesday, 18 October 2022 (9:00 - 5:00PM)
12.0RAC 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.
Europe Europe
In-Person In-Person

Cybersecurity

Thursday, 20 October 2022 (9:00 - 5:00PM)
12.0RAC 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.
Books Books

The European In Vitro Diagnostic Regulation

Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.