Regulatory NewsRegulatory News
FDA blasts California firm for multiple GLP issues involving nonclinical studies
Posted 11 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinical studies at West Sacramento, CA firm Valley Biosystems in a 3 August warning letter and blasted the fi...
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
EMA reports slow uptick in clinical trial applications submitted via CTIS portal
Posted 03 August 2022 By Joanne S. Eglovitch
The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 29 July report from the Eu...
Regulatory NewsRegulatory News
DIA: Experts offer advice on conducting decentralized trials
Posted 24 June 2022 By Joanne S. Eglovitch
There is an unprecedented level of support among regulators to advance the adoption of decentralized clinical trials, yet companies that undertake this mode of research need to be mindful of some of the challenges that can derail these e...
Regulatory NewsRegulatory News
FDA’s OPDP takes Althera to task over cholesterol drug promotion
Posted 07 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has admonished Althera Pharmaceuticals for misrepresenting the efficacy and risk profile of its cholesterol-lowering drug Roszet (rosuvastatin and ezetimibe) in promotional materials. The agency ...
Regulatory NewsRegulatory News
FDA takes steps to relax blood donor requirements
Posted 23 May 2022 By Ferdous Al-Faruque
The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to...
Regulatory NewsRegulatory News
Califf uses budget hearing to advocate for resources, authority to monitor supply chains
Posted 19 May 2022 By Ferdous Al-Faruque
A House appropriations subcommittee hearing on the proposed budget for the US Food and Drug Administration placed the agency’s commissioner, Robert M. Califf, on the hot seat, taking criticism for failing to prevent an infant formula sho...
Regulatory NewsRegulatory News
User fee reauthorization bill advances in the House, Senate eyes different riders
Posted 18 May 2022 By Ferdous Al-Faruque
The House Energy and Commerce committee voted unanimously to send legislation to reauthorize the US Food and Drug Administration’s (FDA) user fee programs to the floor in a 55-0 vote. The bill has significantly different riders from one ...
     
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Online Course Online Course
Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
List Price: $640 Member: $465
This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles.
On-demand On-demand
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
On-demand On-demand
PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introductory Medical Writing [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.
Books Books
Regulatory Writing: An Overview, Second Edition
Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmacovigilance [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Manufacturing Practice (GMP) [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Clinical Practice (GCP) [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research.
     
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All Results

Online Course Online Course

Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]

4.0RAC Credits
List Price: $640 Member: $465
This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles.
On-demand On-demand

Sponsored Webcast: eCTD Submission Challenges (On-Demand)

1.0RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.