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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 ...
Regulatory NewsRegulatory News
EU official says ICH Q6B is outdated and needs revision
Posted 01 December 2021 By Joanne S. Eglovitch
The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concep...
RoundupsRoundups
FDA Approvals Roundup: Cytalux, Lyvispah, Caldolor
Posted 01 December 2021 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
ReconRecon
Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate
Posted 01 December 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Public-private initiative expands support for NGS tests
Posted 30 November 2021 By Kari Oakes
A key microbial genome database is being updated and expanded through a public-private partnership, as the US Food and Drug Administration (FDA) works with a health data company and an academic institution to build out the FDA-ARGOS data...
RoundupsRoundups
Asia-Pacific Roundup: TGA defies medtech industry by retaining definition of central circulatory system
Posted 30 November 2021 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) is keeping its definition of the central circulatory system (CCS) despite universal support for change among medtech respondents to a consultation.
Regulatory NewsRegulatory News
ICH recaps progress made over past year, charts new topics
Posted 29 November 2021 By Joanne S. Eglovitch
The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the ...
Regulatory NewsRegulatory News
FDA offers draft guidance for registries as RWD
Posted 29 November 2021 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) released draft guidance on the use of registries in regulatory decision making, adding another piece to the puzzle of how the agency will consider real-world data (RWD) when considering a new dru...
Virtual Programs Virtual Programs
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications
Thursday, 16 December 2021 (9:00 - 2:00PM) 6.0 RAC Credits Member: $580 Non-Member: $680
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
Virtual Programs Virtual Programs
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements
Wednesday, 01 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 Non Member: $0
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
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.
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 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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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 Huvepharma Maintains Quality and Innovation in a High Growth Environment
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
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
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.
On-demand On-demand
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Learn to Comply With China's UDI Submissions Requirements
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.
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.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Advertising and Promotion in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides information regarding the primary US agencies regulating medical devices and covers their enforcement tools as well as company strategies for avoiding enforcement actions.

All Results

On-demand On-demand

Meet the Author, International Combination Products, First Edition

Member: $0.00 Nonmember: $20.00
Hear from the expert who wrote the book!
Books Books

International Combination Products (Paperback)

Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.