Steering Your Path to the Clinic
How confident are you in your route to the clinic? There are multiple hurdles to be navigated, many of which can knock your development programme off course and threaten that all-important milestone. Optimising your clinical study design, so that it delivers the endpoints you need, without wasting time and budget, is crucial to keeping your programme on track.
Simbec-Orion is delighted to host this Breakfast Workshop where, after you enjoy a delicious selection of filled rolls, fruit and pastries, you can learn how with the right planning ahead of time, you can avoid many of the pitfalls that can often derail early clinical programmes.
Our presenter, Dr Kirsty Wydenbach, who is Head of Regulatory Strategy at Weatherden and is a member of our Clinical Pharmacology Advisory Board, has over 13 years’ experience as an Expert Medical Assessor at MHRA within the Clinical Trials Unit. Kirsty was also involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including ATMPs and many first-in-man studies and was previously an EMA expert for the update of the First-in-Human guideline.
Kirsty’s presentation will be followed by some case studies focussing on trial design and key learnings for early phase clinical pharmacology studies.
Bring your questions and join us for breakfast!
The event will open at 8.30 for a 9am start and conclude at 11am on Thursday June 29th at
The Magdalen Centre
1 Robert Robinson Avenue
There is a visitors car park but should that be full attendees can park on the middle or top floor of the multi-storey car park opposite. Please note that you must not park on the ground floor as these spaces are allocated to the tenants in the building.
Buffet breakfast: tea/coffee & filled rolls, fruit platters & pastries
8:30am Arrival & breakfast
9:00am Introductions & presentation by Dr Kirsty Wydenbach
9:45am Case studies presented by Simbec-Orion
10:15am Discussion & questions to the panel
11:00am Closing remarks & departure