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
Best Practices for Building An Efficient Literature Review Process
1.0 RAC 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.
On-demand On-demand
21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices
1.5 RAC 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.
On-demand On-demand
Learn to Comply With China's UDI Submissions Requirements
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.
On-demand On-demand
How to Effectively Talk to Regulators
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the dos and don’ts of communicating with a regulator, including examples of industry effectively working with FDA.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Dietary Supplements and NHPs [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of the regulatory requirements for dietary supplements in the US and for NHPs in Canada.
Online Course Online Course
Pharmaceutical Labeling: Introduction to an Essential Function
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is designed to expand the understanding of regulatory professionals about the activities, documents, and responsibilities involved in labeling healthcare products.
On-demand On-demand
CMC - An Integral Component of Cell and Gene Therapy Development
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
On-demand On-demand
A Risk-Based Approach to Validation for Life Sciences Companies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.

All Results

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]

6.0RAC 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]

4.0RAC 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]

3.0RAC 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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

REMS and RMPs [3.0 RAC]

3.0RAC Credits
Member: $365 Nonmember: $500
This course provides an overview of the history of risk management, reviews risk management philosophies and examines regulatory requirements and interactions between industry and regulators in the US, EU and Canada
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Quality System Regulation (QSR) [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: Canadian Regulations [6.0 RAC]

6.0RAC 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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: US Regulations [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Understanding and Managing the US Clinical Trial Process [4.0 RAC]

4.0RAC Credits
Member: $465 Nonmember: $640
This course provides an overview of the foundation for clinical trials in the US including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research
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]

4.0RAC 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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Regulation of Combination Products [3.0 RAC]

3.0RAC Credits
Member: $365 Nonmember: $500
This course provides a historical perspective on combination product regulation in the US, and examines the current regulations and policies covering the identification, jurisdiction and review of combination product