Feature ArticlesFeature Articles
The value of a ready-to-use therapeutic food guideline for severe malnutrition
Posted 12 August 2022 By Louise T. Göttsche, MSc, MBA
Ready-to-use therapeutic foods (RUTFs) are used in the treatment of children with severe acute malnutrition (SAM) without medical complications. This article focuses on the value of an RUTF guideline. Knowing what is required for childre...
Regulatory NewsRegulatory News
FDA-led study highlights tradeoffs in drug promotion on social media
Posted 11 August 2022 By Mary Ellen Schneider
Providing both benefit and risk information within character-space-limited (CSL) drug promotions on social media platforms like Twitter improved recognition of risks but made it less likely that consumers would click links for additional...
RoundupsRoundups
Euro Roundup: MDCG posts guidance on notified bodies
Posted 11 August 2022 By Nick Paul Taylor
MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro diagnostic notified bodies. The text also covers the reassessment and is intended to “bring consistency a...
Regulatory NewsRegulatory News
FDA Official: EU privacy regulations impede BIMO inspections, application reviews
Posted 10 August 2022 By Ferdous Al-Faruque
According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General...
Regulatory NewsRegulatory News
Study: Accelerated approval pathway working as intended in most cases
Posted 10 August 2022 By Jeff Craven
Over the last several decades, the US Food and Drug Administration’s (FDA) accelerated approval program has largely been working as it was designed to, with about half the products using the pathway being converted to traditional approva...
Regulatory NewsRegulatory News
Drugmakers request changes to FDA’s mass balance studies guidance
Posted 09 August 2022 By Joanne S. Eglovitch
The pharmaceutical industry is calling for changes to the US Food and Drug Administration’s (FDA) draft guidance on radiolabeled mass balance studies, suggesting the guidance be revised to require fewer subjects, and mention a male prefe...
Regulatory NewsRegulatory News
Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation
Posted 09 August 2022 By Ferdous Al-Faruque
When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling eff...
RoundupsRoundups
Asia-Pacific Roundup: Malaysian device authority posts code of ethics and conduct
Posted 09 August 2022 By Nick Paul Taylor
Malaysia’s Medical Device Authority (MDA) has released a code of ethics and conduct that describes its approach to subjects such as conflicts of interest, confidentiality and the receipt of gifts.
Combination Products Summit 2022
Monday, 07 November 2022 (8:30 - 5:00PM) 0.0 RAC Credits Since 2015, the Combination Products Summit has united the healthcare products industry to work for a better tomorrow.
Virtual Programs Virtual Programs
REC Webinar: Due Diligence
Friday, 09 September 2022 (4:00 - 5:15PM) 1.0 RAC Credits Learn how to approach Due Diligence with respect to acquisitions of products and intellectual property, requiring critical RA & QA/QMS competencies from both a buyers' and sellers' perspective, thereby guiding the process from both sides.
In-Person In-Person
Europe Europe
Regulatory Leadership
Tuesday, 18 October 2022 (9:00 - 5:00PM) 0.0 RAC Credits Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
Chapter Events Chapter Events
San Francisco Chapter Webcast: Cannabis: Where Are We Now?
Tuesday, 04 October 2022 (10:00 - 11:30AM) 1.5 RAC Credits Member: $0 |Nonmember: $25
This webcast will describe the terminology, and differences between FDA-approved and non-FDA approved cannabis, as well as an overview of current regulations of cannabis based products
PharmaLink 2022
Tuesday, 15 November 2022 (8:30 - 5:00PM) 0.0 RAC Credits Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization, and our industry, and most importantly, the patients.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Wednesday, 28 September 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | NonMember: $1150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
In-Person In-Person
Biologics CMC: Regulatory Challenges and Trends
Thursday, 27 October 2022 (9:00 - 3:00PM) 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
Europe Europe
In-Person In-Person
Software as a Medical Device
Thursday, 20 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.
     
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Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Canadian Regulations [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.
Books Books
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the US and Canada [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the EU [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course focuses on the development of healthcare product regulation in the European Union (EU). It discusses the responsibilities of agencies involved, processes employed and interactions among agencies.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Supplier Management [3.0 RAC]
6.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Biosimilars [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is for regulatory professionals interested in biosimilar development and regulatory approval strategies.
Books Books
Fundamentals of EU Regulatory Affairs, Ninth Edition
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.