Regulatory NewsRegulatory News
European Parliament endorses legislation bolstering EU’s ability to tackle shortages
Posted 20 January 2022 By Joanne S. Eglovitch
The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.
ReconRecon
Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list
Posted 20 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA offers examples of innovative study designs accepted into CID pilot
Posted 20 January 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex Innovative Trial Designs (CID) pilot meet...
RoundupsRoundups
Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation
Posted 20 January 2022 By Nick Paul Taylor
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove u...
RoundupsRoundups
FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq
Posted 19 January 2022 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
ReconRecon
Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer arm
Posted 19 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA extends temporary halt in inspections driven by omicron
Posted 19 January 2022 By Michael Mezher
The US Food and Drug Administration (FDA) has extended its temporary pause on non-mission-critical domestic surveillance inspections through 4 February 2022, an agency spokesperson told Focus on Wednesday.
Regulatory NewsRegulatory News
Califf, experts eye legislative fix for accelerated approval program
Posted 19 January 2022 By Mary Ellen Schneider
Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might b...
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Cybersecurity Unauthorized
Tuesday, 08 March 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $970 | Nonmembers: $1,150
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
In-Person In-Person
Executive Development Program at the Kellogg School of Management
Sunday, 22 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
Europe Europe
In-Person In-Person
Software as a Medical Device
Tuesday, 18 October 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.
Virtual Programs Virtual Programs
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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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.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825|Nonmember: $970
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in US, Europe, and other regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 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.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 08 December 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Non-member: $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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Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Supply Chain Controls [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides a review of common supply chain issues and addresses how agencies like FDA encourage organizations to improve supply chain controls.
On-demand On-demand
How to Effectively Talk to Regulators
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the dos and don’ts of communicating with a regulator, including examples of industry effectively working with FDA.
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.
On-demand On-demand
Update Your Medical Device UDI Data and Labels: This Year FDA Class I / Next Year EU MDR
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Join speakers from Reed Tech Life Sciences and NiceLabel for an interactive webcast focused on two compliance areas they are monitoring closely.
On-demand On-demand
The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment
1.0 RAC Credits
Member: $0 Nonmember: $20
This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.
On-demand On-demand
Driving Innovation: Planning for CTD Submissions with Language Excellence
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
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Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
FDA Law and Regulation [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides an overview of FDA and its associated laws and regulations.
On-demand On-demand
How to Better Manage Quality and Risk with a Global Change Control Strategy
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.