Topic

Articles

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.

ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?

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.

FDA CID Paired Meeting Requests for Q3 Open

Webcasts

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

To Validate SaaS or Not to Validate SaaS? That is the Question…

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

How Modeling Can Help to Improve Children’s Access to Properly Evaluated Medications

 enables universal access to clinical research for patients and providers by providing decentralized clinical trials through our platform and unified technology.

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

Navigating the FDA's Draft Guidance on DCTs—A Roadmap for Trial Sponsors

Director, Pharmacovigilance & QPPV, Navitas Life Sciences

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. 


Spontaneous Reporting System for Adverse Drug Reactions in Germany

Insights from Clinical Quality Oversight Forum.

Cultivating a Culture of Quality

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


DIA 2023: Medical Device Regulators and Harmonization

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

DIA 2023: FDA Rare Disease Town Hall

Webinar Date/Time:
Thu, Jul 20, 2023 11:00 AM EDT