Regulatory NewsRegulatory News
Accelerated Approval: Experts weigh in on the role of RWE in confirmatory trials
Posted 08 August 2022 By Mary Ellen Schneider
As Congress considers how to reform the US Food and Drug Administration’s (FDA) controversial pathway for providing accelerated approval to drugs that treat serious or life-threatening diseases, there may be an expanded role for real-wor...
Regulatory NewsRegulatory News
Manufacturers that are not testing DSCSA data systems now are in 'big trouble'
Posted 08 August 2022 By Joanne S. Eglovitch
While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these syst...
ReconRecon
Recon: Senate passes major drug pricing reforms; Pfizer to buy Global Blood Therapeutics for $5.4B
Posted 08 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: EtO, user fee woes, and product specific guidances
Posted 05 August 2022 By Ferdous Al-Faruque
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week the Environmental Protection Agency (EP...
Regulatory NewsRegulatory News
FDA announces website for complex generics
Posted 05 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.  
Regulatory NewsRegulatory News
Studies highlight role of US patent system in limiting competition
Posted 05 August 2022 By Mary Ellen Schneider
“The [US Patent and Trademark Office] would benefit from creating an expert unit for pharmaceutical patent examination, supported by experts from FDA, and giving patent examiners more time to review pharmaceutical patent applications,” r...
RoundupsRoundups
Euro Roundup: Industry wants clarity on links between EHDS, existing legislation
Posted 04 August 2022 By Nick Paul Taylor
MedTech Europe said “the EHDS is a pioneering initiative and has the potential to empower patients [and] accelerate the European Single Market for digital health and data by tackling barriers to cross-border data sharing.” While EHDS is ...
ReconRecon
Recon: FDA approves first interchangeable biosimilar for Lucentis eye drug; Amgen to acquire ChemoCentryx for $4 billion
Posted 04 August 2022 By Joanne S. Eglovitch
Clinical Trials, Data Security Among US Federal Enforcement Priorities  Drug promotion enforcement so far similar under new FDA chief, with just 4 letters in first half of 2022  Accelerated Assessment Dry Spell Over As EMA Says Yes T...
Chapter Events Chapter Events
Utah Chapter Webcast: ISO 13485 and the FDA QMSR
Tuesday, 09 August 2022 (1:00 - 2:00PM) 1.0 RAC Credits Member: $0 |Nonmember: $25
This session is designed to inform the attendees about the FDA’s proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation.
Virtual Programs Virtual Programs
US Regulation of Advertising and Promotion for Drugs and Biologics (2022)
Thursday, 11 August 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 | Nonmembers: $680
Examine requirements, guidelines, and expectations for advertising and promotion of pharmaceuticals in the US.
Virtual Programs Virtual Programs
China Drug Market Opening Up for Foreign Drug Makers
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
Chapter Events Chapter Events
Twin Cities Chapter Happy Hour
Thursday, 18 August 2022 (5:00 - 7:00PM) 0.0 RAC Credits Join us again as the RAPS Twin Cities Chapter hosts another summer Happy Hour!
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
REC Webinar: Due Diligence
Friday, 09 September 2022 (4:00 - 5:15PM) 1.0 RAC Credits Learn how to approach Due Diligence with respect to acquisitions of products and intellectual property, requiring critical RA & QA/QMS competencies from both a buyers' and sellers' perspective, thereby guiding the process from both sides.
In-Person In-Person
RAPS Convergence 2022
Sunday, 11 September 2022 (8:00 - 5:00PM) 12.0 RAC Credits Members: $1,940 | Nonmembers: $2,255
Don’t Miss Regulatory’s Premiere Annual Event!
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.
     
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On-demand On-demand
Best Practices on MDR Transition Under Current Conditions (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
E-books E-books
Quality Management Systems for Drugs and Devices (e-book)
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
On-demand On-demand
FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
On-demand On-demand
Sponsored Webcast: Making Sense of FDA's 2021 Real-World Evidence Guidance (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.
On-demand On-demand
Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices
1.0 RAC Credits
Member: $0 NonMember: $25
Four authors from the latest RAPS book, Global Pediatric Development of Drugs, Biologics, and Medical Devices, will be on hand to answer all your burning questions on global pediatric development in regulatory affairs.
On-demand On-demand
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
On-demand On-demand
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)
6.0 RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.

All Results

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.
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
Single Certificate Single Certificate

Regulatory Affairs Certificate Upgrade: Medical Devices

Member: $1230 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Pharmaceuticals, you can complete the two remaining core courses of the Dual Certificate and three additional electives.
Online Course Online Course
Single Certificate Single Certificate

Regulatory Affairs Certificate Upgrade: Pharmaceuticals

Member: $1230.00 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.
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: EU Regulations [6.0 RAC]

6.0RAC Credits
Member: $570.00 Nonmember: $790.00
This course provides an overview of the regulations and legislative framework, as well as the EMA entities responsible for medicinal product reviews.
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
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Introductory Medical Writing [3.0 RAC]

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

Regulation of US & EU Biologics [5.0 RAC]

4.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: Definition & Lifecycle [1.0 RAC]

1.0RAC Credits
Member: $135.00 Nonmember: $185.00
This course also provides an introduction to the lifecycle of drug products, from discovery to on-market support.