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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EU official says ICH Q6B is outdated and needs revision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FDA offers draft guidance for registries as RWD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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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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Combination Products [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides a historical perspective on combination product regulation in the US, and examines the current regulations and policies covering the identification, jurisdiction and review of combination product
On-demand On-demand
Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
Artificial Intelligence: A Regulatory Perspective
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
The Aftermath of MDR
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
Three Real-World Experiences Using a Novel Data Platform
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.