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International Clinical Trials
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The European clinical research industry is in a period of great
uncertainty. As it reckons with current trends – such as a decline in
favourability as a clinical trial destination in favour of the Asia
Pacific (APAC) region and other geographies – it is simultaneously
bracing itself for other changes on the horizon. These upcoming changes
are largely regulatory in nature; new regulations are related to
advanced therapy medicinal products (ATMPs) and medical devices, which
could both add and relieve headaches for researchers (1). Also, the new
Clinical Trial Regulation is coming in 2019. Furthermore, after Brexit
takes effect that same year, the UK may exempt itself from the
Regulation, possibly creating complexities and uncertainties both there
and in the post-Brexit EU (2).
Then there is the Greater Data
Protection Regulation (GDPR): a vast set of rules and guidelines aimed
largely at securing the personal data of EU citizens stored and
processed online. While designed for the protection of Europeans, the
effects of the GDPR are by no means limited to Europe: EU nationals
anywhere in the world are protected by the new law – the personal data
of a German citizen living and working in Australia, for example, would
be covered – lending it significance on a global level. Given its
breadth and its imminence (the law is set to take effect in May of this
year), it behooves one to examine the context from which it emerged, as
well as how the clinical research industry falls within its scope.
Indeed, clinical research and the healthcare industry, at large – which
stores massive quantities of personal data in formats such as electronic
medical records and clinical trial databases – is bracing for the
impact of the GDPR on its operations. What events set the stage for the
GDPR, how will it affect Europe’s status as a clinical trial
destination, and how can organisations ensure compliance?
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News and Press Releases |
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PCI Pharma Services Announces Appointment of Angi Calkins as Chief Human Resources Officer
Philadelphia, PA – January 28, 2019. Leading biopharmaceutical services provider PCI Pharma Services (PCI) is pleased to announce the appointment of Angi Calkins as Senior Vice President and Chief Human Resources Officer. Angi joins PCI as the company experiences considerable growth and global expansion, currently with more than 3,500 associates, spanning eight locations comprised of 20 facilities across three continents. PCI features a broad portfolio of outsourced development and commercialization services focused in drug development and manufacturing, clinical trial supply, as well as commercial contract packaging.
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Industry Events |
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CPhI & P-MEC China
18-20 June 2019, SNIEC, Shanghai, China
CPhI & P-MEC China 2019 is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new business or getting the latest market insight, this is your one-stop shop pharmaceutical platform in Asia.
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