ReconRecon
Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition
Posted 05 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Asia-Pacific Roundup: TGA updates uniform recall procedure
Posted 05 July 2022 By Nick Paul Taylor
Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the ...
This Week at FDAThis Week at FDA
This Week at FDA: User fee timeline, bivalent boosters, and more
Posted 01 July 2022 By Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the ag...
Regulatory NewsRegulatory News
FDA tells Dutch API producer to clean up its equipment act
Posted 01 July 2022 By Joanne S. Eglovitch
A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Admin...
TrackersTrackers
COVID-19 therapeutics tracker
Posted 01 July 2022 By Jeff Craven
Updated 01 July with new information on Paxlovid, Evusheld, molnupiravir, Regkirona and ivermectin.
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition
Posted 01 July 2022 By Ryan Connors
Regulatory professionals need a new guide to medical device regulations. We just wrote one.
Feature ArticlesFeature Articles
Supply chain disruptions: FDA guidance and temporary policies
Posted 30 June 2022 By Tony Subketkaew, JD, Joanna Pearce, JD
The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents...
Feature ArticlesFeature Articles
Proposed updates hint at dietary supplement legislative reform
Posted 30 June 2022 By Krista Hekking, JD, Miriam Guggenheim, JD
The dietary supplement industry has grown in the 28 years since the passage of the Dietary Supplement Health and Education Act (DSHEA), but the legislative reform has not been commensurate with those industry changes. This article discus...
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.
Chapter Events Chapter Events
Ontario Chapter Webcast: What, Why and When of Postmarket Clinical Follow-up
Thursday, 21 July 2022 (12:00 - 1:00PM) 1.0 RAC Credits PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.
Virtual Programs Virtual Programs
Root Cause Investigation for CAPA
Tuesday, 26 July 2022 (11:00 - 3:00PM) 12.0 RAC Credits Member: $970| Nonmember: $1150
Investigative tools used to identify technical root causes, systemic root causes, corrective and preventive actions, and control plans to monitor and prevent recurrence.
Chapter Events Chapter Events
Indiana Chapter Webcast: Challenges and Lessons Learned from Both an Industry and Notified Body Perspective for the Implementation of EU Regulations
Tuesday, 26 July 2022 (3:30 - 5:00PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join regulatory professionals for an overview of key learnings obtained on the journey to MDR and IVDR certification.
Virtual Programs Virtual Programs
Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
Wednesday, 03 August 2022 (10:00 - 11:00AM) 1.0 RAC Credits Member: $0 | NonMember: $0
In this webcast, experts will review the history of quality systems, look at the changes to quality regulations, and discuss the FDA’s intent to adopt the ISO 13485 standard.
Virtual Programs Virtual Programs
Tackling the CMC Challenges for Cell and Gene Therapy Product Development
Wednesday, 03 August 2022 (12:00 - 2:00PM) 2.0 RAC Credits Price: Member: $195 / Nonmember $230
Key opinion leaders from academia, industry, and a regulatory agency will discuss these strategies in addressing CGT manufacturing challenges to bring transformative medicines to patients.
Virtual Programs Virtual Programs
Setting the Standard for Real-World Evidence: Research Methods and Data Quality for Medical Devices
Friday, 05 August 2022 (12:00 - 1:30PM) 6.0 RAC Credits Member: $150 NonMember: $175
Key principles and considerations in designing and executing a real-world evidence study for medical-device evaluation will be outlined.
Virtual Programs Virtual Programs
US Regulation of Advertising and Promotion for Drugs and Biologics (2022)
Thursday, 11 August 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 | Nonmembers: $680
Examine requirements, guidelines, and expectations for advertising and promotion of pharmaceuticals in the US.
     
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On-demand On-demand
2020 NMPA (CFDA) Key Updates and Look Ahead on 2021
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal, and to know when to file for modifications to avoid penalties?
On-demand On-demand
A Risk-Based Approach to Validation for Life Sciences Companies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.
Books Books
Regulatory Intelligence 101, Third Edition
Member: $130.00 Nonmember: $180.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Chemistry, Manufacturing and Controls (CMC) [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides an overview of the CMC section of dossiers.
On-demand On-demand
Most Common Findings in EU Clinical Evaluations
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the most common findings identified by Notified Bodies and by Qserve when performing a final CER review to the requirements of the MDR and MEDDEV 2.7/1 rev.4.
On-demand On-demand
The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.
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.
On-demand On-demand
Meet the Authors, Regulatory Writing, Second Edition
1.0 RAC Credits
Member: $0.00 Nonmember: $0.00
Hear from the experts who wrote the book on regulatory writing. Authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will discuss the new edition’s writers-eye view of regulatory documentation.

All Results

Books Books

Essentials of Healthcare Product Labeling

Member: $130.00 Nonmember: $180.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
On-demand On-demand

Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Join us for a regulatory professional’s presentation on Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets.
On-demand On-demand

Best Practices for Regulatory Compliant Literature Review

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
You will gain an understanding of practical considerations to help you conduct a high-quality literature review to produce quality data output for your CERs.
On-demand On-demand

Achieving 21 CFR 11 Compliance with Cloud-Deployed Systems

1.0RAC 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.
Books Books

Fundamentals of US Regulatory Affairs, 11th Edition

Member: $147.50 Nonmember: $197.50
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
On-demand On-demand

Regulatory Intelligence and Its Value in Regulated Industry

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
The fundamentals of global regulatory intelligence, and how it can be used to influence regulatory decision making throughout a development program and lifecycle management of a therapeutic product.
On-demand On-demand

How to Facilitate Regulatory Meetings

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation.
Books Books

Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations

Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
On-demand On-demand

What You Need to Know About FDA Regulation of Medical Product Promotional Labeling

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will discuss considerations for implementing quality systems and procedures that will help you remain in compliance with promotional labeling regulations.
On-demand On-demand

Successfully Integrating Cybersecurity Risk Management into International Regulatory Submissions

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will focus on how cybersecurity risk management impacts international regulatory submissions and more.