Regulatory NewsRegulatory News
Califf previews priorities if confirmed as FDA commissioner
Posted 18 January 2022 By Michael Mezher
In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better p...
RoundupsRoundups
Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests
Posted 18 January 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance...
Regulatory NewsRegulatory News
GAO tasks FDA with developing agency-wide workforce plan for medical product staff
Posted 17 January 2022 By Jeff Craven
Centers within the US Food and Drug Administration (FDA) are using the flexibility in hiring and pay requirements afforded by the 21st Century Cures Act (Cures Act) to recruit and retain medical staff, but the agency does not have a wo...
Regulatory NewsRegulatory News
This Week at FDA: User fee update, Califf nomination, and more
Posted 14 January 2022 By Michael Mezher
Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming years, as well as many other updates and actions from the agency. We hear that HHS has transm...
TrackersTrackers
COVID-19 vaccine tracker
Posted 14 January 2022 By Jeff Craven
Updated 14 January to include new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Sinopharm, CanSino Biologics, Bharat Biotech/Ocugen, Center for Genetic Engin...
Regulatory NewsRegulatory News
Senate committee advances Califf’s nomination as FDA commissioner
Posted 13 January 2022 By Michael Mezher
The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).
Regulatory NewsRegulatory News
Stakeholders seek clarity on FDA cell and gene therapy draft guidance
Posted 13 January 2022 By Jeff Craven
Industry, medical societies and other stakeholders have weighed in on draft guidance from the US Food and Drug Administration (FDA) detailing how sponsors that want to study multiple versions of cell and gene therapies could combine them...
RoundupsRoundups
Euro Roundup: EDQM pushes forward with ‘CEP of the future’ after positive feedback
Posted 13 January 2022 By Nick Paul Taylor
The European Directorate for the Quality of Medicines (EDQM) will spend the first half of 2022 designing the Certificate of Suitability (CEP) after a consultation revealed support for its plan to revise the content and layout document.
Virtual Programs Virtual Programs
Talking to Decision Makers: What to Say and How to Say It (April 2022)
Friday, 22 April 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $195 | Nonmember: $230
Position yourself for success by learning how to succinctly communicate with executives. This event will teach you how to explain issues clearly and how to make yourself an invaluable asset to senior leadership.
Virtual Programs Virtual Programs
Talking to Decision Makers: What to Say and How to Say It (September 2022)
Friday, 23 September 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $195 | Nonmember: $230
Position yourself for success by learning how to succinctly communicate with executives. This event will teach you how to explain issues clearly and how to make yourself an invaluable asset to senior leadership.
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: 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 | Non-member: $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
Software as a Medical Device
Tuesday, 25 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 |Nonmember: $1,150
Join regulatory experts to explore evolving global regulatory requirements affecting SaMD, including determining when software is considered regulated as SaMD and how to determine correct class/classification.
Virtual Programs Virtual Programs
Sponsored Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
Wednesday, 23 February 2022 (12:00 - 1:00PM) 1.0 RAC Credits Members: $0 | Nonmembers: $0
Attend this live broadcast and learn the essentials of e-PIL legislation, a pilot initiative between the pharm industry and regulatory authorities in Belgium and Luxembourg, supported by the European Commission
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.
     
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On-demand On-demand
Argumentation and Persuasion for Regulatory Professionals
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
Books Books
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
Books Books
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
Books Books
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Effective Regulatory Communication [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
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.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Project Management for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.
On-demand On-demand
China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.

All Results

On-demand On-demand

Argumentation and Persuasion for Regulatory Professionals

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to utilize structures to think through argumentation.
Books Books

Eclectic Science and Regulatory Compliance: Stories for the Curious

Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
Books Books

Communication and Negotiation

Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
Books Books

Choosing the Right Regulatory Career

Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Effective Regulatory Communication [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.