The Drug Information Association chose Amsterdam for its two European conferences regarding implementing the new EU clinical trials regulation and complying with global disclosure and transparency requirements for medicinal products and medical devices. Both events are held this December at the Mercure Hotel Amsterdam City.
Clinical Trial Regulation Conference
The conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes, including the new EU clinical trials Regulation but also conducting novel complex innovative design trials.
Regulators and other decision-makers, together with various experts in the field, will debate how the new legislation will impact the processes for the design, submission and approval, and managing European clinical trials in the future.
The event will be held on December 2-3, 2019, at Mercure Hotel Amsterdam City.
See more on https://www.diaglobal.org/en/conference-listing/meetings/2019/12/clinical-trial-regulation-conference
Clinical Trial Disclosure & Data Transparency Conference
The event will focus on the latest challenges and opportunities resulting from EMA, Health Canada and National Institutes of Health data disclosure & transparency policies. The attendants will gain insights on different approaches to navigate and comply with global disclosure and transparency requirements for medicinal products and medical devices.
Other hot subjects will be discussed: the impact of the EU General Data Protection Regulation (GDPR) on data sharing; various strategies for preparing for the implementation of the EU Clinical Trials Regulation; the impact of Brexit on MHRA and disclosure requirements; how new ICMJE data sharing requirements are being implemented; what approaches sponsors are taking for redaction and anonymization; and updates on sponsor compliance.
This 2019 Conference builds on prior conference discussions and leverages learnings from Regulators and international experts in the field.
The event will be held on December 4-5, 2019, at Mercure Hotel Amsterdam City.
Read more at https://www.diaglobal.org/en/conference-listing/meetings/2019/12/clinical-trial-data-transparency-conference
Source: https://www.diaglobal.org/
