RoundupsRoundups
Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions
Posted 21 October 2021 By Nick Paul Taylor
The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking fe...
Regulatory NewsRegulatory News
FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires
Posted 21 October 2021 By Joanne S. Eglovitch
Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administratio...
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.
Regulatory NewsRegulatory News
EMA shares lessons learned from biosimilars pilot
Posted 19 October 2021 By Joanne S. Eglovitch
The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the...
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.
Regulatory NewsRegulatory News
FDA adcomm unanimous on J&J boosters for all
Posted 15 October 2021 By Kari Oakes
The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19 vaccine made by Janssen, the vaccines arm of Johnson & Johnson, for all recip...
Regulatory NewsRegulatory News
CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz
Posted 15 October 2021 By Michael Mezher
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended six new medicines for marketing authorization in the EU.
Virtual Programs Virtual Programs
Expedited Pathways (US/Global) – Medical Device
Monday, 15 November 2021 (8:30 - 4:15PM) 12.0 RAC Credits Led by a veteran regulatory manager, this workshop will focus on expedited pathways by FDA, EU, China NMPA and other regulatory agencies from major global markets as to map out a pathway to bring products to market as fast as possible.
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
Getting a Seat at the Table: Optimizing the Role of the Regulatory Professional
Friday, 05 November 2021 (1:00 - 2:30PM) 1.5 RAC Credits Member $160 Nonmember $175 Learn how to run an effective regulatory team and how to get your colleagues to work with you and not against you.
Virtual Programs Virtual Programs
Biologics CMC: Future Trends, Current Trends and Regulatory Challenges
Tuesday, 02 November 2021 (9:00 - 4:00PM) 12.0 RAC Credits This workshop provides an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other regulated regions.
Virtual Programs Virtual Programs
The Aftermath of MDR
Tuesday, 09 November 2021 (12:00 - 1:30PM) 1.5 RAC Credits Delve into the challenges that Notified Bodies and industry are experiencing during the transition from MDD to MDR. Glean expertise from the industry’s early adopters with real-world examples from device manufacturers by attending this live webcast.
Virtual Programs Virtual Programs
Europe Europe
Regulatory Considerations for Advanced Therapies & RNA-based Therapeutics
Thursday, 09 December 2021 (2:00 - 6:00PM) 6.0 RAC Credits Advanced therapies entail challenges at any stage of product development. We will provide an overview of the regulatory landscape for product development and discuss regulator considerations for specific product types based on case studies.
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.
Chapter Events Chapter Events
Utah Chapter Webcast: MDD to EU MDR transition – Will MyLegacy Product Portfolio Get Certified Under the EU MDR?
Thursday, 21 October 2021 (9:00 - 10:30AM) 1.5 RAC Credits Member: $10 Nonmember: $25 Don’t miss this unique opportunity to explore the transition from MDD to EU MDR with two subject matter experts.
     
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On-demand On-demand
Argumentation and Persuasion for Regulatory Professionals
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Effective Regulatory Communication [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Globalization of Clinical Research Trials and Investigations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Project Management for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.
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.
Books Books
Key Regulatory Topics: eCTD (Paperback)
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
Books Books
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD (Paperback)
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
Books Books
Eclectic Science and Regulatory Compliance: Stories for the Curious (Paperback)
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.

All Results

On-demand On-demand

Argumentation and Persuasion for Regulatory Professionals

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Effective Regulatory Communication [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Globalization of Clinical Research Trials and Investigations [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Project Management for Regulatory Professionals [4.0 RAC]

4.0RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.