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
EMA, HMA outline evolution of DARWIN EU real-world database
Posted 02 August 2022 By Ferdous Al-Faruque
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) plan to launch an ambitious new database to collect real-world data (RWD) from a slew of studies that reviewers can reference for their regulatory decision-mak...
Regulatory NewsRegulatory News
FDA official: Patients play an increasing role in rare disease drug development
Posted 01 August 2022 By Mary Ellen Schneider
Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful clinical benefits, according to Kerry Jo Lee, MD, associate director of rare diseases in the US Food and Drug Administration’...
Regulatory NewsRegulatory News
This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report
Posted 29 July 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 US Food and Drug Administration (F...
Regulatory NewsRegulatory News
FDA explains the ins and outs of real-time oncology review program in new guidance
Posted 26 July 2022 By Ferdous Al-Faruque
Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as well as easy to interpret endpoints, may qualify for a head-start review from the US Food and Drug Administration (FDA...
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Personalized medicine growth hindered by outmoded drug development paradigm
Posted 11 July 2022 By Joanne S. Eglovitch
There has been explosive growth in the number of applications and approvals for personalized medicines, yet the current drug development paradigm is not optimizing the development of these treatments, asserted Kenneth Getz, the executive...
Regulatory NewsRegulatory News
Oligonucleotides: FDA drafts clinical pharmacology guidance
Posted 27 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) last week issued draft guidance spelling out its expectations for the types of clinical pharmacology assessments that should be conducted during the development of oligonucleotide therapies. The ...
Europe Europe
In-Person In-Person
Effectively Coping with the European IVD Regulation
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1080 | Nonmembers: € 1,264
Although much is clear in the IVD-R text, as the saying goes "the devil is in the details" and there are lots of areas still open to interpretation and which need further guidance.
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.
On-demand On-demand
The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.
On-demand On-demand
Plan to Accelerate Your Time to Drug Submissions
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
We'll discuss each stage of the submission, variations such as size of the development program, type of submission, and dealing with governance bodies.
On-demand On-demand
PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Intermediate Medical Writing: Medical Devices [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course provides an overview of some of the more complex documents prepared by regulatory and medical writers, including key sections of the Premarket Approval and 510(k) Premarket Notification applications
On-demand On-demand
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the EU [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course focuses on the development of healthcare product regulation in the European Union (EU). It discusses the responsibilities of agencies involved, processes employed and interactions among agencies.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Intermediate Medical Writing: Pharmaceuticals and Biologics [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will provide an overview of some of the more complex documents prepared by regulatory and medical writers, with a focus on the Common Technical Document (CTD).
E-books E-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.
     
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