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ReconRecon
Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron
Posted 02 December 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
New reports address generics pricing, innovation in the EU
Posted 01 December 2021 By Kari Oakes
A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation ...
ReconRecon
Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine
Posted 24 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partners with Arrowhead for NASH drug
Posted 23 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Pfizer touts long-term efficacy data for COVID vaccine in adolescents; House panel seeks interview with Hahn
Posted 22 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Euro Roundup: EFPIA calls for EU to drive reform of WTO, shares feedback on emergency authority
Posted 18 November 2021 By Nick Paul Taylor
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on the European Union to take the lead on the reform of the World Trade Organization (WTO). The pharma trade group sees the 12th ministerial WTO con...
ReconRecon
Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antiviral drug
Posted 18 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies
Posted 16 November 2021 By Joanne S. Eglovitch
The European Medicine Agency’s (EMA) Committee for Medicinal Products (CHMP)   last week recommended 11 new medicines for approval in the EU, including Europe’s first two new monoclonal antibodies for treating COVID-19. The agency also ...
In-Person In-Person
Europe Europe
Software as a Medical Device
Tuesday, 15 February 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1,120
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
In-Person In-Person
Europe Europe
Cybersecurity
Thursday, 17 February 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1120
Gain the knowledge you need to navigate global cybersecurity expectations, translate regulatory expectations into concrete design and development activities and establish trust with customers.
In-Person In-Person
Europe Europe
Effectively Coping with the European IVD Regulation
Tuesday, 15 February 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1,120
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.
In-Person In-Person
Europe Europe
The EU Clinical Trial Regulation
Friday, 18 February 2022 (9:00 - 12:00PM) 6.0 RAC Credits Members: € 550 Nonmembers: € 650
Learn how changes for assessment and approval of multinational clinical trial authorization applications will impact trials conducted inside and outside the EU to avoid delays and minimize the time for approval.
Virtual Programs Virtual Programs
Europe Europe
In-Person In-Person
RA Considerations During Clinical Development in the EU
Thursday, 17 February 2022 (9:00 - 4:00PM) 6.0 RAC Credits Members: € 555 Nonmembers: € 650
Learn which aspects to consider when writing a regulatory plan, along with several pathways to speed up development, including PRIME and adaptive pathways.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Tuesday, 14 December 2021 (9:00 - 4:00PM) 12.0 RAC Credits Member: $800 Nonmember: $900
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 20 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Receive an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in the US, Europe, and other regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
     
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Books Books
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
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.
Books Books
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.
Books Books
Lifecycle Management Through the Rx-to-OTC Switch (Paperback)
Member: $125.00 Nonmember: $175.00
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 (Hardcover)
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

Software as a Medical Device

Tuesday, 15 February 2022 (9:00 - 5:00PM)
12.0RAC Credits
Members: € 945 Nonmembers: € 1,120
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.