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BioLearn: Clinical Trials-Roles & Responsibilities - Oxfordshire

OBN

Tuesday, 9 June 2020 from 09:00 to 17:00 (BST)

BioLearn: Clinical Trials-Roles & Responsibilities -...

Ticket Information

Ticket Type Sales End Price Fee VAT
Quantity
OBN Member
This ticket type is available for OBN Members. To check if you are a Member, or to inquire about OBN Membership please contact membership@obn.org.uk
9 Jun 2020 £250.00 £16.74 £53.35
Non-member
This ticket type is available for non-members. To check if you are a Member, or to inquire about OBN Membership please contact membership@obn.org.uk
9 Jun 2020 £350.00 £23.24 £74.65

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Event Details

Clinical Trials: Roles & Responsibilites 

 

This course is an interactive, practical overview of the process of clinical development of medicinal products and the responsibilities of the various parties, with an emphasis on sponsor oversight

 

The course will be of benefit to those whose organisations are either in the process of, or about to embark on, clinical development of a new medicinal product.


It will also be of benefit to those who are weighing up the decision whether to undertake clinical development themselves or to license the product out.

 

Course content:

The Clinical Trials Process

What is a clinical trial?

Phases of clinical

Lifecycle of a clinical trial


Regulatory Requirements

Introduction to key requirements


EU Clinical Trials Legislation

Current legislation

Implementation of new EU Clinical Trials Regulation

Key changes to clinical trial conduct

Practical implications for clinical trial conduct

Impact of Brexit


Clinical Trials in the UK

MHRA and HRA Approvals

UK Legislation

The Grey Guide


Sponsor Oversight

Sponsor responsibilities

Vendor management

Demonstrating oversight


Risk in Clinical Trials

Risk assessment

Risk proportionate approaches to clinical trials


FDA

US legislation – 21CFR

Main differences between US and EU requirements

Conducting IND trials outside the US – pros and cons

 

Course Information & Costs:

This is a full-day course usually taking place between 09:00 – 17:00. Costs include catering and all course materials.

 

OBN Members - £250 + VAT

Non-members - £350 + VAT

 

For more information or to request an invoice please email: sarah.walker@obn.org.uk or call: 01235 420 881

Do you have questions about BioLearn: Clinical Trials-Roles & Responsibilities - Oxfordshire ? Contact OBN

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When & Where


The Oxford Science Park
Robert Robinson Avenue
OX44GA Oxford
United Kingdom

Tuesday, 9 June 2020 from 09:00 to 17:00 (BST)


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Organiser

OBN

OBN is the not-for-profit Membership organisation supporting and bringing together the UK’s innovative life sciences companies, corporate partners and investors. Our 400-plus Member companies are located across the Golden Triangle and beyond to Nottingham, Manchester and Scotland benefiting from our networking, partnering, purchasing, training, advising and advocacy activities.

 

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