ReconRecon
Recon: Biden admin embarks on effort to develop next-gen COVID-19 vaccines; EU approves Bavarian Nordic’s Monkeypox vaccine
Posted 25 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP
Posted 19 July 2022 By Maurice Bancsi, PhD
It can take at least a year to 18 months to get a new medicinal product approved in the US, European Union, or United Kingdom. Over the last decade, regulators have introduced initiatives to shorten the time to market for medicines that ...
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.
ReconRecon
Recon: FDA signals support for updated COVID vaccines; EMA recommends BioMarin’s hemophilia gene therapy
Posted 27 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Moderna to study COVID vaccine in babies 3 to 6 months of age; Walgreens enters clinical trial business
Posted 16 June 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: FDA staff indicates support for Bluebird gene therapy; FDA expert panel reviews Novavax vaccine
Posted 07 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
PIC/S resuming onsite and desktop assessments this year
Posted 06 June 2022 By Joanne S. Eglovitch
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced plans to restart inspections for countries applying for membership, though it said these audits will be subject to available resources and other priorities. Inspections ...
ReconRecon
Recon: Pfizer seeks EUA for COVID vaccine for kids under 5; Regeneron buys rights to Sanofi cancer drug for up to $1.1B
Posted 02 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
     
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In-Person In-Person
Cybersecurity Unauthorized
Tuesday, 11 October 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 regarding global cybersecurity expectations.
Virtual Programs Virtual Programs
Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success
Wednesday, 24 August 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.
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 - 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
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
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 04 October 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 NonMembers: $1,150
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
Virtual Programs Virtual Programs
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions
Wednesday, 05 October 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
On-demand On-demand
How to Facilitate Regulatory Meetings
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation.
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
Giving Voice to Regulatory Leadership
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the professional development skills you need for success.
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
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.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Intermediate Medical Writing: Investigational Applications [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course provides an overview of the variety of investigational applications prepared by regulatory and medical writers for both drugs/biologics and medical devices.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
FDA Law and Regulation [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides an overview of FDA and its associated laws and regulations.
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.

All Results

In-Person In-Person

Cybersecurity Unauthorized

Tuesday, 11 October 2022 (9:00 - 5:00PM)
12.0RAC 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 regarding global cybersecurity expectations.
Virtual Programs Virtual Programs

Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success

Wednesday, 24 August 2022 (11:00 - 12:00PM)
1.0RAC Credits
Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.
On-demand On-demand

Best Practices for Building An Efficient Literature Review Process

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks.
Virtual Programs Virtual Programs

Biologics CMC: Phase Appropriate Product Development

Wednesday, 28 September 2022 (9:00 - 4:00PM)
12.0RAC 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 - 4:00PM)
12.0RAC 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
On-demand On-demand

21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices

1.5RAC Credits
Member: $0.00 Nonmember: $35.00
The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.