Regulatory

New laws leave consumers unprotected against third parties accessing their genetic data.

Agency will be reorganizing field force and compliance functions.

Exploring the implications of FDA’s renewed focus and commitment to expand the use of accelerated approval for gene therapy products.

EU proposal focuses on a subset of underserved rare diseases—exploring the gaps in those conditions for which there is no approved treatment option.

Cleve talks about the future of the industry and how data remains a key focus.

Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.

Webinar Date/Time: Thursday, October 26th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Stepped-up training and real-time application key to avoiding compliance pitfalls.

How to support trial investigators through decentralization of trial elements.

Perceived barriers of DCTs can be quickly overcome to ensure their viability in clinical research.

Webinar Date/Time: Tue, Sep 19, 2023 11:00 AM EDT

With lessons from COVID now established, concrete ideas on improving drug development strategy for future health threats are beginning to take shape.

How will AI best be positioned to help safety professionals best utilize their time and resources?

Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.

Designed to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs, the program provides an opportunity for sponsors to interact with experts from FDA.

Webinar Date/Time: Wednesday, September 13th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Regulatory guidance paves the way to address ethical concerns in pediatric trials, and how additional strategies can be applied in drug evaluation.

Webinar Date/Time: Wednesday, August 16, 2023 at 11am EDT

While underreported, ADR data offers significant value to the drug development value chain to refine the predictive capability and stability, and provide enhanced patient safety.

Insights from Clinical Quality Oversight Forum.

Session at DIA discusses the International Medical Device Regulators Forum (IMDRF), its importance and how harmonization could be improved.

CDER and CBER leaders update initiatives in the rare disease space within the past year.

Webinar Date/Time: Thu, Jul 20, 2023 11:00am EDT | 4pm BST | 5pm CEST

First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.