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RoundupsRoundups
Asia-Pacific Roundup: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback
Posted 17 May 2022 By Nick Paul Taylor
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in light of industry feedback on the draft proposal. Medsafe is retaining the proposed 4.2% increase across all fees but making...
Regulatory NewsRegulatory News
IVDR: Commission adds risk management standard to harmonized standards list
Posted 16 May 2022 By Michael Mezher
The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
ReconRecon
Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA’s RWE pilot cites challenges in emulating RCTs
Posted 16 May 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Posters highlight research, regulatory updates at Euro Convergence 2022
Posted 10 May 2022 By Mary Ellen Schneider
This year’s RAPS Euro Convergence features research and updates on the use of new technology and regulatory tools as part of the conference’s poster session.
Regulatory NewsRegulatory News
FDA drafts guidance on medical device voluntary improvement program
Posted 09 May 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP) that uses third-party appraisals to evaluate manufacturing practi...
Regulatory NewsRegulatory News
Pharmaceutical industry groups suggest ICH Q9 changes
Posted 06 May 2022 By Joanne S. Eglovitch
The proposed revisions of the International Council of Harmonization’s (ICH) Q9 (R1) guideline on risk management should be better aligned with medical device quality risk standards as well as international standards. Further, a firm’s i...
Feature ArticlesFeature Articles
April’s Regulatory Focus: Specialist vs. generalist, RI, and more
Posted 06 May 2022 By Renee Matthews
Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an ...
Regulatory NewsRegulatory News
IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback
Posted 06 May 2022 By Ferdous Al-Faruque
Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from the International Medical Device Regulators Forum (IMDRF).
Chapter Events Chapter Events
Colorado Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships
Thursday, 23 June 2022 (4:00 - 5:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
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.
Virtual Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Tuesday, 07 June 2022 (8:00 - 12:00PM) 12.0 RAC Credits Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970|Nonmember: $1,150
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 region
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | Nonmember: $1,150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Europe Europe
In-Person In-Person
Software as a Medical Device
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1,080 | Nonmembers: € 1,265
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
Coming Soon Coming Soon
Biologics CMC: Future Trends
Thursday, 27 October 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $1,100 | Nonmember: $1,300
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 regions
In-Person In-Person
Cybersecurity Unauthorized
Monday, 27 June 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
     
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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.
Books Books
Complete GHTF Guidance Document Bundle
Member: $62.50 Nonmember: $82.50
A GHTF bundle of 24 guidances for medical devices: 10 from Study Group 1, eight from Study Group 2, three from Study group 3, two from Study Group 4 and one from Study Group 5.
On-demand On-demand
Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)
1.5 RAC Credits
Member: $0 NonMember: $25
Learn to leverage electronic QMS systems to build compliance. This live broadcast will debunk QMS myths and address the challenges in ensuring data integrity.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Understanding and Managing the US Clinical Trial Process [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides an overview of the foundation for clinical trials in the US including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research
On-demand On-demand
How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The webcast features lessons learned from the COVID-19 pandemic about leveraging risk management and quality management systems to maximize business success in times of disruption and digital transformation.
Books Books
Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
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.
On-demand On-demand
Achieving 21 CFR 11 Compliance with Cloud-Deployed Systems
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
We'll describe the challenges faced by small FDA-regulated companies in managing and controlling the content of eTMF, eCTD and QMS.
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.