This course has been specifically designed for people working in NHS clinical research who would benefit from taking one day out to focus on structuring and reviewing contracts and to participate in a legal clinic. By being part of this day will not only receive up-to-date information and practical examples, but in this structured, yet interactive format, you will be able to hear other attendees’ reactions and feedback to what is being presented.
Many attendees to this event completed an evaluation form, and we are pleased to share with you some of the comments made about this day:
Highly relevant content and been very usefulUniversity Hospital of South Manchester
Impressive and exceeded expectationsunknown
Useful background to clinical research contactsKeele University
Knowledgable speakers and good programmeHampshire Hospitals NHS Foundation Trust
Very hands-on training with specific examples that will help me in my daily workNHS Blood and Transplant
The documentation from Advanced Strategies to Structure & Review Clinical Research Contracts which took place on 20 April 2016 in Leeds, includes the following presentations:
- Clinical Research Contracts: Understanding the Nuances - •Examining what is included in the clinical research model contract •Sharing practical insight: simplifying terminology and levels of coverage explained • Reviewing different elements of contract risk •Allocation of rights and responsibilities, and governance check •Unmasking essential confidentiality, indemnity and intellectual property issues •Practical hints and tips on setting out and embedding finances •Model non-commercial clinical trial agreement (mNCA) and material transfer agreements
- Making Modifications to the Standard Model Contracts for Clinical Research - •Exploring the suite of model contracts: what they cover and when to use them •Sharing examples of common areas of negotiation and modifications, and avoiding classic pitfalls •Gaining legal insight into acceptable changes: ensuring you are covered •Inclusion of foreign law provisions when working with international companies
- Contracting Outside of the Clinical Research Model Agreement Remit - •Understanding the range of clinical studies and their different contracting needs •Reviewing the benefits and risks of formal contracts vs. appropriate documentation •What key areas should trusts focus in on for nonstandard agreements? •A quick guide to Human Tissue Agreements: when might the protocol be enough? •Best practice sub-contracting outside the NHS and between NHS organisations •Foreign sponsors: overcoming the tricky aspects of working with the US and Europe • Understanding the requirements of IMP Manufacturing
- Legal Clinic: Common Areas of Dispute and Practical Examples of Clinical Research Contracts - •Avoiding disputes: essential insight to safeguard your interests •Practical guidance and experienced reassurance: quick legal insight into areas of concern • Examples and case studies of common hurdles and trip points for NHS Trusts
Conference documentation in both hard and electronic copy is available for purchase at £89 (there is no VAT charge). In addition to being posted a copy, all the documentation is now available to you in electronic format so that you can access the papers and presentations online.
Please email the customer service team or telephone 01732 897788 stating the name and date of the event you would like to purchase documentation for. Payment is required in advance and this can be done by requesting an invoice or immediately using a debit card.
On receipt of payment you will be given immediate access to the presentations on-line where they will be in a pdf format. You will also be sent a set of documentation in the post.
Thank you for attending an SBK: Healthcare course. We are pleased to offer you on-line access to the documentation that you received at the event. This is an exclusive benefit for all of the attendees and includes additional and updated documentation.
Please enter your email address and password which is at the front of your documentation pack. The password will also be emailed to you after the event and this is your notification that the documentation is available on-line.
If you are having any difficulty please contact firstname.lastname@example.org or telephone 01732 897788.