PCMG Interactive Workshop
April 2nd 2019, Crowne Plaza Hotel Copenhagen

How has our industry implemented GDPR?

What is current best practice and how can Outsourcing Management maintain compliance?

What challenges lie ahead?

DOWNLOAD FULL AGENDA

DOWNLOAD REGISTRATION FORM

The introduction of the General Data Protection Regulation (GDPR) on 25^th May 2018 significantly changed how personal data should be processed.  Compliance within the pharmaceutical has been more straight forward than in many other industries, in part because of an existing and deep-rooted respect for sensitive, personal medical information and the absolute requirement for subject confidentiality.  Nevertheless a great deal of additional work has been required within the industry to ensure compliance with the new regulations, including process analyses, changes in internal policies and contract renegotiation and alignment with third parties. One year on, we will take a look back on our learnings; how has the industry implemented GDPR? What is current best practice for GDPR compliance?  And what challenges still lie ahead?

The worksop is open to pharma employees and also to CRO/service provider employees with roles that are impacted by GDPR.  The workshop is not sponsored and is therefore open to all; in this way we will be addressing GDPR from the perspectives of both Data Processors and Data Controllers. 

Workshop topics:

This workshop will address lessons learned through the implementation of GDPR in Drug Development. We will discuss different perspectives on the realities of GDPR compliance, as follows:

• Examine GDPR implementation from the viewpoint of the sponsor, the CRO, the EFPIA/EMA and Investigational sites in clinical research;
• Define and share best practice with regards to the contracting processes, handling different types of personal data in different areas of drug development and practical implications in outsourcing;
• Assess the risks and practical obstacles on the path of implementing GDPR

Speakers will include an outsourcing specialist, data protection experts and two Board level legal counsel of substantial international companies, from both pharma and CRO organisations.  We will also hear how at least one company implemented GDPR within their clinical function, warts and all!  Probably more lawyers than we have ever had at a PCMG workshop!

ATTENDANCE IS OPEN TO PCMG MEMBERS, THEIR DELEGATE OR PHARMA NON-MEMBERS (£175 + VAT, REFUNDABLE AGAINST FULL 2019 MEMBERSHIP) AND TO CRO/SERVICE PROVIDER EMPLOYEES WHOSE ROLE IS IMPACTED BY GDPR (£175 + VAT)

PCMG IS FULLY FUNDING THIS EVENT AND WILL BE ENCOURAGING CONTRIBUTIONS FROM DELEGATES DURING THE DAY TO ENRICH THE DISCUSSIONS AND TO HELP TO DEFINE BEST PRACTICES.