As professionals in the life sciences industry, we work in a regulated environment and we are a key element in the compliance process of our organisations to the regulations and guidelines in place. In addition to Clinical Good Practices (i.e. ICH E6) and other ICH guidelines, most countries in Europe have adopted data privacy laws since many years, and in May 2018, the General Data Protection Regulation (GDPR) came into force in the European Union. 14 other countries outside Europe have privacy laws in adequation with GDPR and GDPR is becoming the gold standard to protect the private life of citizens.
The Healthcare and Life Sciences industries have not been waiting for the GDPR to protect the rights of patients, and many measures have been in place for years already with the Code of Nuremberg in 1947 and the Convention of Helsinki in 1964, just to name a few.
Our industry is probably the most advanced in that matter. Does this mean that all principles of the GDPR are already included in the regulations and guidelines in our sector? No, there are new aspects that every clinical data manager needs to know in order to guarantee that the data management process is compliant.
This webinar will cover the following topics:
- GDPR presentation and description of interplay between ICH and GDPR
- Focus: regulatory constraints surrounding data reuse through use case