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Clinical trials and the GDPR: do I really need the participant’s consent? (Altius)

Author: Alexander Schillebeeckx (Altius) Publication date: 02/05/2019 On 23 January 2019, the European Data Protection Board (EDPB) issued its Opinion 3/2019 on the interplay between the General Data Protection Regulation (GDPR; applying since 25 May 2018) and the Clinical Trials Regulation (CTR; probably applying from 2020). In its Opinion, the EDPB

Does your clinical trial pass the GDPR test? (Loyens & Loeff)

Author: Stéphanie De Smedt (Loyens & Loeff) Date of publication: 12/10/2018 Since 25 May 2018, the General Data Protection Regulation (“GDPR”) is applicable throughout Europe. Strictly regulating the processing of health data, international data transfers and contractual arrangements between the parties involved in a clinical trial, the GDPR has had

Belgium adopts law to prepare for Clinical Trials Regulation implementation (Allen & Overy)

On 20 April 2017, the Law on clinical trials with medicines for human use was adopted to ensure the practical implementation of the EU Clinical Trials Regulation (CTR) in Belgium. The law aims at strengthening Belgium’s position at the forefront of medical research within the EU (Belgium is preceded only

2017-05-12T15:07:10+00:00 12 mai, 2017|Categories: Droit médical Pharma & lifesciences|Tags: , |

Pharmaceutical companies outsourcing clinical trials to group companies may pay substantially more taxes (Bird & Bird)

A patent or innovation box is a type of tax incentive in the form of an exemption, deduction or reduced corporate income tax rate for certain income arising from the exploitation of IP. In most countries, the IP was limited to patents (hence, the “patent box”), but some countries also