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Interplay between ICH and Data Privacy – GDPR

Post thumbnail Interplay between ICH and Data Privacy – GDPR

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
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    Featured Speakers

    Bertrand Le Bourgeois thumbnail
    Bertrand Le Bourgeois
    President of PharMarketing GDPR Life Sciences
    Bertrand Le Bourgeois graduated as an engineer from Ecole Centrale in France, with a marketing specialisation from HEC Business School. He has spent his career in Management and IT Consulting, in the healthcare and life science industries at major service providers for Clinical Research and Data Management, and as CIO for a key manufacturer. Now Bertrand runs PharMarketing GDPR Life Sciences, a consulting firm which helps life sciences companies to become compliant with Data Privacy Regulation in Europe (GDPR) ,in the US and abroad, with Good Data Management and Good Clinical Practices (GCP) and with IT Good Practices (GAMP, ISO 27001). PharMarketing also provides Legal Representation in the EU and UK for Data Privacy and other EU schemes, performs CSV and audits. Bertrand is Vice-Chair of the Association for Clinical Data Management and is President of the French Association of Medical Professionals for Healthcare Products Industry (AMMIS).
    Seamus Larroque thumbnail
    Seamus Larroque
    CEO of iliomad
    As CEO Seamus is in charge of the business development aspects of iliomad Health Data. Seamus ensures the establishment of long-term and strategic partnerships while developing the relationship with patient organisations. Seamus brings more than six years of experience in the pharmaceutical industry, having held various positions at Servier Laboratories and at Voisin Consulting Life Sciences (VCLS).
    Pierre Malvoisin thumbnail
    Pierre Malvoisin
    COO of illiomad
    As Chief Operating Officer of iliomad Health Data, Pierre is responsible for the implementation of health data protection services, in order to offer a tailor-made service adapted to the specificities of the different medical research activities (Clinical Trial, Medical Device, AI, …), including the different applicable regulations (European regulations, local laws, Good Clinical Practices, …).