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.
Books Books
Fundamentals of US Regulatory Affairs, 11th Edition (2022 Update)
Member: $205.00 Nonmember: $275.00
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
On-demand On-demand
SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies
Member: $0.00 Nonmember: $20.00
This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss the keys to commercial success.
On-demand On-demand
Are You Ready to Begin Planning your IND Submission?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.
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
Global Regulatory Strategy for Medical Devices [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic description of global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development.
On-demand On-demand
What You Need to Know About FDA Regulation of Medical Product Promotional Labeling
1.5 RAC 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.
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.

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.