The following Life Sciences practice note Produced in partnership with Eveline Van Keymeulen of Allen & Overy and Marco de Morpurgo provides comprehensive and up to date legal information covering:
This Practice Note covers the new Regulation (EU) 536/2014 on clinical trials, the Clinical Trials Regulation (CTR). It reviews the main changes introduced by the CTR to the EU regulatory framework applicable to clinical trials, and discusses the key aspects that clinical trial sponsors and pharmaceutical companies must be aware of as the CTR application date approaches.
On 16 April 2014, the European Parliament and the Council of the EU adopted Regulation (EU) 536/2014 on clinical trials on medicinal products for human use, the CTR.
From its date of application (which is expected to be during 2021, see: Application date), the CTR will repeal and replace the current regulatory regime for clinical trials laid down by Directive 2001/20/EC (consolidated version) on clinical trials on medicinal products for human use, the Clinical Trials Directive (CTD), as amended, and implementing legislation of the EU Member States.
The regulatory framework on clinical trials established by the CTD was widely criticised by stakeholders for being too fragmented and for having increased the regulatory burden and costs of conducting clinical trials in the EU, resulting in a significant decline in the number of trials conducted in the EU since the adoption of the CTD (there had been a reduction of about 25% at the time of adoption of the CTR).
With the objective of re-establishing
**Trials are provided to all LexisPSL and LexisLibrary content, excluding Practice Compliance, Practice Management and Risk and Compliance, subscription packages are tailored to your specific needs. To discuss trialling these LexisPSL services please email customer service via our online form. Free trials are only available to individuals based in the UK. We may terminate this trial at any time or decide not to give a trial, for any reason. Trial includes one question to LexisAsk during the length of the trial.
To view the latest version of this document and thousands of others like it, sign-in to LexisPSL or register for a free trial.
Existing user? Sign-in
Take a free trial
On 29 August 2015, the Prudential Regulation Authority (PRA) published the PRA Rulebook (Rulebook). The transition from the Handbook to the Rulebook was intended to benefit PRA-authorised firms, to access clearer and more concise rules. Alongside the Rulebook, supervisory statements and statements
The offence of causing grievous bodily harm with intentWounding or causing grievous bodily harm (GBH) with intent is triable only in the Crown Court on indictment. Elements of the offence Under the Offences against the Person Act 1861 (OATPA 1861), the prosecution must prove the defendant unlawfully
Involuntary manslaughter—introductionManslaughter can be classified as either voluntary or involuntary. Voluntary manslaughter consists of those killings which would be murder (because the accused has the relevant mental element—hence the label voluntary manslaughter) but which are reduced to
This Practice Note considers the legal concept of mistake in contract law. It examines common mistake, mutual mistake, unilateral mistake, mistake as to identity and mistake as to the document signed (non est factum). It also considers the impact of each of these types of mistake on the contract and
0330 161 1234
To view our latest legal guidance content,sign-in to Lexis®PSL or register for a free trial.