DIA workshop on the EMA policy 0070: Maxer partecipation
Maxer participated in the workshop The Evolution of Policy 0070: EMA Clinical Data Publication that was organised by the Drug Information Association (DIA) and took place in London on December 6-7. Over 80 people form regulatory authorities, pharmaceutical industries, and consulting agencies participated in the event. Among the most relevant issues the lecturers dealt with:
- The impact of the EU Clinical Trial Regulation and EMA Policy 0070 on trial disclosure business processes
- The upcoming legal requirements related to disclosure of clinical research information for medicinal products and medical devices
- The Real-world experiences on implementation of the regulations, including optimising processes to meet the requirements for disclosure, data sharing, and data transparency.
The presence of many EMA exponents stimulated numerous question on behalf of the sponsors, most of all focused on the anonymisation and the proposal of redaction of the Commercially Confidential Information (CCI).
Also, the sessions dedicated to the tools for anonymising clinical documents in line with the policy 0070 proved to be highly interesting.