Regulatory NewsRegulatory News
EMA wants participants to serve on clinical trial multistakeholder forum
Posted 03 February 2023 By Joanne S. Eglovitch
The European Medicines Evaluation Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are calling for representatives from the research community, pharmaceutical sponsors, academics and regulators to particip...
Regulatory NewsRegulatory News
This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
Posted 03 February 2023 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 agency announced the launch of a ...
Regulatory NewsRegulatory News
FDA draft guidance addresses clinical development of drugs to treat early Lyme disease
Posted 02 February 2023 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs to treat the early stages of Lyme disease.  
Regulatory NewsRegulatory News
Shuren: FDA needs new authorities to prevent device shortages beyond public health emergencies
Posted 02 February 2023 By Ferdous Al-Faruque
The head of the US Food and Drug Administration’s (FDA) device center says he will continue to work with Congress and the medtech industry to pass legislation to prevent potential medical device shortages before a public health emergency...
ReconRecon
Recon: US FDA gives thumbs up to GSK anemia drug; Vax makers kept $1.4 billion in COVID shot prepayments
Posted 02 February 2023 By Joanne S. Eglovitch
COVID-19 tracker: Merck pill linked to new mutations, study says  FDA: Patients Can Get Paxlovid, Lagevrio Even With Negative COVID Test Europe pharma sector risks lagging the world, say drug chiefs  Draft WHO pandemic deal pushes f...
Regulatory NewsRegulatory News
FDA draft guidance addresses use of external controls to assess effectiveness of new drugs and biologics
Posted 02 February 2023 By Joanne S. Eglovitch
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors can leverage external controls, such as use data from registries and electr...
RoundupsRoundups
Euro Roundup: EMA shares guidance on CTR, confidential data as new rules take effect
Posted 02 February 2023 By Nick Paul Taylor
The quick guide covers the basics of CTR, explaining the key principles of the regulation before walking through the steps sponsors should take before starting clinical trials. EMA explains how to register users, products and organizatio...
Sponsored ContentSponsored Content
Medical device software regulations in the EU and US
Posted 01 February 2023 By Carrie Hetrick
Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements. Medical device software is bound by ...
Feature ArticlesFeature Articles
Update on FDA regulation of ophthalmic combination products
Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards ha...
Regulatory NewsRegulatory News
FDA proposes streamlining inspections office along with new human foods center
Posted 31 January 2023 By Ferdous Al-Faruque
The US Food and Drug Administration has proposed restructuring the Office of Regulatory Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes will eventually mean more efficiencies...
Regulatory NewsRegulatory News
FDA releases FY 2022 generic drug research summary
Posted 31 January 2023 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year 2022 in 13 different scientific areas under the Generic Drug User Fee Amendments ...
Feature ArticlesFeature Articles
Subpart H and the implications for ad promo
Posted 31 January 2023 By Yash Thaker, PharmD
Advertising and promotion (ad promo) of prescription drugs is regulated by the US Food and Drug Administration (FDA). In 1992, the agency implemented Subpart H of Title 21 of the Code of Federal Regulations (CFR) to allow for the acceler...
Virtual ProgramsVirtual Programs
Cybersecurity Unauthorized (Feb 2023)
Tuesday, 07 February 2023 (9:00 - 4:00PM) 12.0 RAC Credits Members: $970 | Nonmembers: $1,150
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
Virtual ProgramsVirtual Programs
Business Writing for Regulatory Professionals: Making It Easy (Feb 2023)
Wednesday, 15 February 2023 (1:00 - 3:00PM) 2.0 RAC Credits Member: $230 | NonMember: $270
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise.
Virtual ProgramsVirtual Programs
How to Submit a DMF to China’s NMPA: Practice Points and Latest Updates
Thursday, 16 February 2023 (10:00 - 11:30AM) 1.5 RAC Credits Member: $175 | NonMember: $200
This workshop will provide a thorough understanding of China NMPA Drug Master Filings (DMF). By attending, regulatory professionals and manufacturers will better position themselves to meet new requirements.
Virtual ProgramsVirtual Programs
RAPS Webcast: Streamlining Conformity Assessment in Device Submissions: FDA’s ASCA Program
Thursday, 16 February 2023 (11:00 - 12:00PM) 1.0 RAC Credits Price: Free
Introductory webcast for participants to the webcast for participants to the FDA's ASCA, a program in which manufacture.rs may contract with ASCA-accredited test labs to perform testing to certain consensus standards
In-PersonIn-Person
EuropeEurope
FDA Pre-Submissions: The Most Valuable Tool in Your US Regulatory Toolbox
Tuesday, 21 February 2023 (9:00 - 5:00PM) 12.0 RAC Credits €975 Member|€1155 Nonmember
This 2-day workshop will review the multiple types of pre-submissions, or Q-submissions, available to manufacturers and how to leverage these to reduce the time and costs to bring medical devices to market in the U.S.
In-PersonIn-Person
EuropeEurope
Technical Equivalence
Tuesday, 21 February 2023 (9:00 - 5:00PM) 12.0 RAC Credits Price: € 975 Member | € 1,155 Nonmember
This 2-day workshop will explore the topic of the pathway to establish technical, biological and clinical equivalence for EU conformity versus substantial equivalence pathways for the FDA.
Virtual ProgramsVirtual Programs
Software as a Medical Device (SaMD) (Feb 2023)
Tuesday, 21 February 2023 (10:00 - 4:00PM) 12.0 RAC Credits Member $970 | Non-Member $1150
Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD).
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
DC/ Baltimore Chapter: FDA Compliant Use of Smartphones, Apps and Technology in Clinical Trials
Wednesday, 22 February 2023 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0| Nonmember: $25
Use of wearable devices and smart technology is increasing in clinical trials. This program will discuss the use of Smartphones, Apps and other technology in terms of FDA compliance and practical concerns
Virtual ProgramsVirtual Programs
RAPS Webcast: MDR by The Numbers
Thursday, 23 February 2023 (9:00 - 10:30AM) 1.5 RAC Credits Free
MDR implementation cold, hard, numbers: results of research on recent MDCG guidance, industry and Notified Body surveys, and interviews with stakeholders (including NB) on experiences with implementation.
In-PersonIn-Person
EuropeEurope
Cybersecurity
Thursday, 23 February 2023 (9:00 - 5:00PM) 12.0 RAC Credits € 975Member | € 1155Nonmember
Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization, and our industry, and most importantly, the patients.
In-PersonIn-Person
EuropeEurope
Survivor: the FDA 510(k) Program Edition
Thursday, 23 February 2023 (9:00 - 5:00PM) 12.0 RAC Credits € 975Member | € 1155Nonmember
In this two-day, in-person workshop, you will gain an understanding of the 510(k) program and strategies to help obtain a positive clearance decision.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Insights and Actions from the 2023 Medtech Regulatory Performance Report
Thursday, 23 February 2023 (2:00 - 3:00PM) 1.0 RAC Credits Price: Free
The 2022 Medtech Regulatory Performance survey of 200 medtech regulatory professionals yielded some expected and some unexpected results. We will explore the findings and regulatory predictions for 2023.
     
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Books   |   Learning

On-demandOn-demand
2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webcast, key policies, guidelines, and standards will be reviewed. Manufacturers and Inventors can implement techniques to shorten their time to market.
Virtual ProgramsVirtual Programs
Standards in Medical Device Submissions: Practical Advice on Appropriately Citing Consensus Standards to Reduce Regulatory Burden (On-Demand)
1.0 RAC Credits
This webcast will explain the importance of consensus standards in medical device development and offer practical direction to device firms' regulatory affairs and standards staff about how to correctly cite standards in their submissions.
On-demandOn-demand
RAPS Webcast: Overview PMS Key Updates: China QMS/GMP Compliance per Order 739 (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
This webcast recording will teach you about updated requirements in GMP and post market supervision for State Order 739: “Regulations on Supervision and Administration of Medical Devices"
On-demandOn-demand
FDA Forecast: What's Next for the FDA in 2023? (On-Demand)
1.5 RAC Credits
Member: $0 | NonMember: $25
What will the FDA do in 2023? In this timely, lively and informative event, regulatory analysts from POLITICO's AgencyIQ will explain what regulatory professionals should anticipate in the year ahead.
On-demandOn-demand
Meet the Authors: Postmarket Requirements for Medical Devices (On-Demand)
1.0 RAC Credits
Price: Free
Come meet the lead authors of RAPS latest e-book, Postmarket Requirements for Medical Devices: A Practical Guide. Hear first hand why the book was developed, who the book was developed for, and how you can benefit from reading it
On-demandOn-demand
Sponsored webcast: Navigating the Complex IVDR Landscape (On-demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
This webinar will look closely at the requirements of the EU IVDR, timelines and deadlines and common pitfalls of technical documentation.
On-demandOn-demand
Sponsored Webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 Months (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
On-demandOn-demand
Sponsored webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
On-demandOn-demand
Mastering your 510(k) submission process (On-Demand)
1.0 RAC Credits
Member: $0 | Nonmember: $25
Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
E-booksE-books
Postmarket Requirements for Medical Devices: A Practical Guide (e-book)
Member: $175 Nonmember: $245
Comprehensive guide covering product change evaluation, postmarket surveillance, and compliance with audit/inspection requirements in the medical device industry.
On-demandOn-demand
Sponsored Webcast: Orphan Drug Designation | The Considerations, The Rewards, and How They Differ Between The US and Europe (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why
On-demandOn-demand
Meet the Authors: Nutrition, Health, and Disease: Regulatory Policy Matters (On-Demand)
1.0 RAC Credits
Free
Meet our author and ask questions about RAPS' latest e-book, Nutrition, Health, and Disease: Regulatory Policy Matters.
RAC ExamRAC Exam
RAC Devices Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Devices Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Devices Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
RAC ExamRAC Exam
RAC Drugs Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Drugs Examination Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 2023
RAC ExamRAC Exam
RAC Drugs Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
PreviewPreview
Combination Products Summit 2023
Tuesday, 28 November 2023 (8:30 - 5:00PM)
The 2023 Combination Products Summit is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration. The Combination Products Summit focuses on solutions for a dynamic industry with evolving regulations
PreviewPreview
Artificial Intelligence Summit
Tuesday, 14 November 2023 (8:30 - 5:00PM)
Since 2017, the AI Summit unites AI experts from industry, regulatory agencies & academia to understand challenges and actionable solutions in healthcare & life sciences. AI Summit 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative.
Coming SoonComing Soon
In-PersonIn-Person
RAPS Convergence 2023
Tuesday, 03 October 2023 (8:00 - 4:00PM)
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 08 September 2023 (1:00 - 2:00PM)
1.0RAC Credits
Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.
Virtual ProgramsVirtual Programs
Regulatory Challenges, Prospects, and Modern Solutions
Thursday, 01 June 2023 (12:00 - 4:00PM)
3.0RAC Credits
Member: $335 | Nonmember: $395
We'll discuss the evolving regulatory landscape, opportunities, challenges, and the emerging use and analytics of real-world data (RWD), specifically, leveraging the innovation of Targeted Learning.
Virtual ProgramsVirtual Programs
Preparing to Take the RAC Drugs Exam (May 2023)
Wednesday, 31 May 2023 (11:00 - 4:00PM)
12.0RAC Credits
Member: $495 | NonMember: $580
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 ProgramsVirtual Programs
Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases
Tuesday, 23 May 2023 (12:00 - 1:00PM)
1.0RAC Credits
Free
Health situations like the COVID-19 pandemic, are urging us to change in the long research procedures restricted by national regulations as information sharing is the key to rapid innovation in the era of Bi.
Virtual ProgramsVirtual Programs
Preparing to Take the RAC Devices Exam
Monday, 22 May 2023 (5:00 - 8:00PM)
6.0RAC Credits
Members: $580|Nonmembers: $680
The sessions will be facilitated by a panel of regulatory professionals who have earned their RAC credential and are subject matter experts in their field.
EuropeEurope
In-PersonIn-Person
2023 Euro Convergence
Wednesday, 10 May 2023 (8:00 - 4:00PM)
12.0RAC Credits
RAPS is pleased to announce that Euro Convergence 2023 will converge in Amsterdam, The Netherlands from Wednesday 10 May to Friday 12 May 2023.
In-PersonIn-Person
Executive Development Program at the Kellogg School of Management
Sunday, 07 May 2023 (9:00 - 4:00PM)
12.0RAC Credits
The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC!
Friday, 05 May 2023 (1:00 - 2:00PM)
1.0RAC Credits
Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.
Virtual ProgramsVirtual Programs
China Drug Registration and Reimbursement Webcast
Thursday, 27 April 2023 (11:00 - 12:30PM)
1.5RAC Credits
Member: $175 | NonMember: $200
This webcast will present information on how to register your drug in China and how pricing or market access is determined. What is the best strategy to register and maximize pricing in China.