This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted
The life science sector is heavily regulated and CTAs are some of the most important agreements for companies operating in this sector. Having appropriate CTAs in place is therefore essential for managing relationships between the different stakeholders, and apportioning risk and responsibilities between them. If appropriate contractual arrangements are not in place, a clinical trial may not receive approval or issues may arise with the integrity or validity of the data collected. Further, disputes between the parties can arise if responsibilities are not clearly defined in the agreement.
This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted. Participants will receive an overview of the legal framework regulating clinical trials in the European Union (and UK), before taking a closer, comprehensive look at specific issues that must be considered when drafting a CTA. Using a case study, participants will also look at some example clauses and will have the opportunity to practise negotiation skills in the safe environment of the course room under the guidance of our expert faculty.
By the end of the programme, you will be more confident in spotting and addressing the key issues that arise when negotiating and drafting CTAs, understand how best to mitigate against the risks and deal with them effectively when they do arise.
Key topics covered in this intensive and interactive seminar:
Attending this seminar will enable you to:
This course will be particularly beneficial to:
Please note:
This interactive session allows participants to practise negotiating specific clauses concerning liabilities and indemnities using skills and techniques to minimise disputes and maximise efficiency. Example clauses will be provided and considered within the group. Participants will be divided into small groups representing the opposite party to practise their negotiation skills.
Alex Denoon (More...)
Alex Denoon is head of the regulatory team at Bristows, primarily advising life sciences clients. He has more than 20 years’ experience advising clients in the sector. In addition to his LLB, Alex has a BSc in Human Genetics. Alex spent more than five years in-house, including as GC and Company Secretary of Biotech Australia. He works with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals and medical devices, and has advised clients in relation to more challenging issues including: genomics, cell therapies, tissue and cells requirements, borderline products, combination products, 3D printing, healthcare apps and remote diagnostics, and has been involved in the development of a number of regulatory frameworks and guidelines.
In addition to a range of contentious (judicial review) and advisory matters, he has a breadth of international experience in structuring, negotiating and drafting commercial agreements. Alex is widely published and speaks regularly at conferences.
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
1 Aug 2022 Live webinar 09:00-17:00 UK (London) |
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1 Aug 2022 Live webinar 09:00-17:00 UK (London) |
GBP 599.00 EUR 859.00 USD 970.00 + VAT @ 20.00% |
Enrol now
to attend Live webinar Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase. |
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4 Nov 2022 Live webinar 09:00-17:00 UK (London) |
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4 Nov 2022 Live webinar 09:00-17:00 UK (London) |
GBP 599 499 EUR 859 719 USD 970 814 Until 30 Sep* |
Enrol now
to attend Live webinar Please note: this event is being organised by our training partner Falconbury; clicking Enrol will take you to falconbury.co.uk to complete your purchase. |
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* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.