Search Results

shopping_cartShopping Cart

Search term: Combination Products

Reset
 

News Search

RoundupsRoundups
Asia-Pacific Roundup: Pakistan’s DRAP issues draft guidelines for good cold chain management
Posted 28 March 2023 By Nick Paul Taylor
DRAP has based the draft guideline on the World Health Organization (WHO) Annex 9 Model guidance for storing and transporting time- and temperature–sensitive pharmaceutical products. The draft uses the same structure as the model guida...
Regulatory NewsRegulatory News
Pharma official: Expect “substantial” revision of ICH stability and specification guidelines
Posted 27 March 2023 By Joanne S. Eglovitch
BASEL, Switzerland – Two upcoming International Council on Harmonization (ICH) guidelines covering stability testing and specification setting are undergoing long-overdue revisions and are expected to be “substantially” revised and, an i...
Regulatory NewsRegulatory News
FDA eases labeling, clarifies IVD requirements in COVID transition guidances
Posted 27 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to traditionally marketed products – but it hasn’t budged on the 180-d...
RoundupsRoundups
Latin America Roundup: Colombia’s top regulator quits after 6 months; was key champion of multi-country agency
Posted 27 March 2023 By Jennie Smith
Rossi’s departure comes amid heated legislative debates about ongoing medication shortages in the country and the role of the regulatory agency in addressing them. Rossi had been a top proponent, along with his counterparts in Cuba and M...
ReconRecon
Recon: FDA to convene adcomm for twice-rejected ALS cell therapy; EU delays pharma legislation for third time
Posted 27 March 2023 By Joanne S. Eglovitch
Pharming’s Leniolisib Gains FDA Approval in Ultra-Rare Disease  California’s Plan for Cheaper Insulin Collides with Big Pharma’s Price Cuts  European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation  Production...
Regulatory NewsRegulatory News
This Week at FDA: Becerra asks for new authorities; FDA issues guidances, reports
Posted 24 March 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. It’s been a busy week for the agency as Xavier B...
Regulatory NewsRegulatory News
FDA outlines plan for digital health technologies for clinical trials
Posted 24 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidanc...
Regulatory NewsRegulatory News
EMA official shares lessons learned from the COVID pandemic
Posted 24 March 2023 By Joanne S. Eglovitch
One process that worked: For promising COVID treatments, EMA was able to provide enhanced presubmission dialogue with sponsors. EMA also was able to conduct “agile” assessments for promising treatments and ensure safety monitoring for th...
Regulatory NewsRegulatory News
Decentralized trials getting some attention on the international regulatory front
Posted 24 March 2023 By Joanne S. Eglovitch
At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed some of the current challenges in conducting decentralized clinical trials in the EU, where differences am...
Regulatory NewsRegulatory News
Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs
Posted 23 March 2023 By Ferdous Al-Faruque
The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track product supply chains to avoid shortages and the need to give incentives to antimicrobial drug manufacturers to deve...
Regulatory NewsRegulatory News
DARWIN EU ‘ramping up quickly’ with more partners coming on board
Posted 23 March 2023 By Joanne S. Eglovitch
“Many people initially who told us they were skeptical of its value understood that when you wanted to evaluate the safety or the effectiveness of the vaccine in everyday rollouts, it was RWE that was answering the critical questions.  A...
RoundupsRoundups
Euro Roundup: MHRA advances major overhaul of UK clinical trial regulation after positive feedback
Posted 23 March 2023 By Nick Paul Taylor
The UK will combine MHRA and ethics reviews and aim to complete assessments within 30 days of the validation of the application. Combining the reviews halved the review time, and reduced the time from application to first patient in, dur...

Event Calendar

PreviewPreview
Combination Products Summit 2023
Tuesday, 28 November 2023 (8:30 - 5:00PM) 0.0 RAC Credits 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
In-PersonIn-Person
Risk Management for the Full Product Life Cycle: Design Concept through Post-Market Surveillance
Tuesday, 18 April 2023 (8:00 - 5:00PM) 12.0 RAC Credits Member: $1340 | Nonmmember: $1570
The session demonstrates an approach to sustain and use a Risk Management File throughout the product life. By attending, manufacturers will be better positioned to meet the latest regulatory requirements.
In-PersonIn-Person
Survivor: The FDA 510(k) Program Edition (April 2023)
Thursday, 20 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Price: Member $1340| Nonmember $1570
2-day, in-person workshop, regulatory experts to review the current requirements & expectations of this evolving program and provide strategies to help ensure success when navigating the FDA 510(k) program
In-PersonIn-Person
Regulatory Strategies & Advice for MedTech Start-up Companies
Tuesday, 20 June 2023 (9:00 - 5:00PM) 6.0 RAC Credits Price: $785 Member | $920 Nonmember
This program will focus on regulatory strategies & pitfalls by considering time-to market & risk aspects. By attending, the RA professional will be able to implement the right strategy in his company.
Virtual ProgramsVirtual Programs
RAPS Webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases
Tuesday, 23 May 2023 (12:00 - 1:00PM) 1.0 RAC 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 (May 2023)
Monday, 22 May 2023 (5:00 - 8:00PM) 6.0 RAC Credits Members: $580|Nonmembers: $680
This workshopwill be facilitated by a panel of regulatory professionals who have earned their RAC credential and are subject matter experts in their field.
In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM) 0.0 RAC Credits For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
In-PersonIn-Person
Executive Development Program at the Kellogg School of Management (May 2023)
Sunday, 07 May 2023 (9:00 - 4:00PM) 12.0 RAC 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.
Chapter EventsChapter Events
Virtual ProgramsVirtual Programs
Ontario Chapter Webcast: Medical Device Software Decoded
Wednesday, 17 May 2023 (1:00 - 2:00PM) 1.0 RAC Credits Member: Free | Nonmember: $25
This webcast will provide an overview of medical device software development challenges and how they can be addressed.
In-PersonIn-Person
Biologics CMC: Phase Appropriate Product Development (April 2023)
Thursday, 27 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Member: $1340 | NonMember: $1570
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual ProgramsVirtual Programs
US Regulatory Essentials, Devices (April 2023)
Tuesday, 04 April 2023 (10:00 - 3:30PM) 12.0 RAC Credits Members: $970| Nonmembers: $1150
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.
Virtual ProgramsVirtual Programs
China NMPA Regulations on IVD and Companion Diagnostics (April 2023)
Tuesday, 11 April 2023 (8:30 - 12:30PM) 12.0 RAC Credits Member: $970 NonMember: $1150
This workshop will focus on the latest NMPA regulations for In Vitro Diagnostics (IVD) products and companion diagnostics (CDx).
     
    •  
  • 1
    •  
  • 2
    •  
  • 3
    •  
    •  

Books   |   Learning

On-demandOn-demand
Sponsored Webcast: Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25 This webcast will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid case report of manufacturers moving through the transitioning to applying the EU MD.
On-demandOn-demand
Insights and Actions from the 2023 Medtech Regulatory Performance Report Event (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
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.
E-booksE-books
Nutrition, Health, and Disease: Regulatory Policy Matters
Member: $145.00 Nonmember: $200.00
This book depicts the importance of nutrition and the gut microbiome in noncommunicable chronic diseases (NCD) prevention and management.
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
Sponsored Webcast: Is Your Labeling an Adverse Event Waiting to Happen? (On-Demand)
1.0 RAC Credits
Price: Member: $0 | NonMember: $25
In this session we’ll explore compliant labeling, examine labeling process gaps, and provide you with the tools to defend a robust labeling process at your organization.
E-booksE-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
On-demandOn-demand
Efficiency and Technology Pave the Way for the New Age of Narrative Writing (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.
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
Ensure Your MDR Program is State of the Art (On-Demand)
1.5 RAC Credits
Member:$0 NonMember:$25
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
On-demandOn-demand
The Aftermath of MDR (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Delve into the challenges that Notified Bodies and industry are experiencing during the transition from MDD to MDR. Glean expertise from the industry’s early adopters with real-world examples
BooksBooks
The European Medical Device Regulation (2021 Update)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
RAC Prep BundleRAC Prep Bundle
RAC (Drugs) Reference Package: Basic
Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Device) Practice Test and Flashcards together and save on these indispensable reference tools—our most popular products to help you prepare.
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 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 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.
Virtual ProgramsVirtual Programs
RAPS eCornell Regulatory Leadership Certificate Program
Wednesday, 01 November 2023 (8:00 - 5:00PM)
12.0RAC Credits
Member: $4250 | Nonmember: $5250 | Enterprise: $4250
RAPS has partnered with eCornell, to bring you a specialized certificate program to help perfect and validate your Diversity, Equity, and Inclusion (DEI) leadership skills
Introduction to ISO 13485
Thursday, 10 August 2023 (9:00 - 1:00PM)
3.0RAC Credits
Member: $335 | NonMember: $395
This half-day introduction will provide you with an understanding of the purpose of a Quality Management System (QMS) and the key principles of ISO 13485:2016.
In-PersonIn-Person
Root Cause Investigation for CAPA (June 2023)
Wednesday, 21 June 2023 (9:00 - 5:00PM)
12.0RAC Credits
Member: $1340 | Nonmember: $1570
Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges, particularly in highly regulated industries.
In-PersonIn-Person
Regulatory Strategies & Advice for MedTech Start-up Companies
Tuesday, 20 June 2023 (9:00 - 5:00PM)
6.0RAC Credits
Price: $785 Member | $920 Nonmember
This program will focus on regulatory strategies & pitfalls by considering time-to market & risk aspects. By attending, the RA professional will be able to implement the right strategy in his company.
Virtual ProgramsVirtual Programs
Software as a Medical Device (SaMD) (June 2023)
Wednesday, 14 June 2023 (9:00 - 4:00PM)
12.0RAC 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
NY/NJ Chapter Webcast: Regulatory Opportunities and challenges with mRNA Technology- Lessons Learned from the COVID-19 Pandemic
Monday, 12 June 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $0 | NonMemeber $25
This webcast will describe the current regulatory framework applicable to mRNA products and explain the regulatory challenges and opportunities that have been enabled with mRNA technology.
Virtual ProgramsVirtual Programs
Clinical Evaluation for Medical Devices
Monday, 12 June 2023 (9:00 - 1:00PM)
12.0RAC Credits
Price: Member: $1125 NonMember: $1290
This training will give you the skills to ensure all the requirements of the EU MDR are met & provide insight into how clinical evaluation is integrated with risk management and post-market surveillance.
Virtual ProgramsVirtual Programs
Regulatory Challenges, Prospects, and Modern Solution
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
RAPS Webcast: 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.