Welcome
This highly acclaimed course will provide training in toxicology as applied in drug development to scientists from all parts of the World. Participants will obtain an overall understanding of the principles of non-clinical safety evaluation with emphasis on the practical application of these principles and interpretation of non-clinical safety data. Regulatory toxicology in drug development will be emphasised, from both a European and a US perspective. Through the week the students will participate in tutored group study of regulatory cases and original data from a regulatory submission which will conclude with a half-day workshop.
The course is intended to benefit individuals from biotechnology and pharmaceutical companies working with either small or large molecules, along with those from CROs, regulatory agencies and academia who are interested in toxicology and its application in safety assessment of drugs and medical products and for toxicologists early in their career seeking more in-depth knowledge and understanding of the role of toxicology in safety assessment. It is also suitable for scientists trained in ancillary disciplines (such as chemistry, biochemistry, molecular biology, medicine, etc.) making a career change to work in drug safety assessment.
This course is recognised by EUROTOX as providing 32 hours of education for continuing professional development. It is approved by the Royal Society of Biology for purposes of CPD and may be counted as 132 CPD credits.
Course Overview
Basic Principles of Toxicology - Ruth Roberts, ApconiX
Pharmacology - Rob Wallis, Safety Pharmacology Consultant
Safety Pharmacology - Rob Wallis, Safety Pharmacology Consultant
General Toxicology - Ruth Roberts, ApconiX
Pharmacokinetics/ADME - Gerry Kenna, Consultant
Organ Systems - John Foster, Consultant Pathologist
Organ Systems - Matt Jacobsen, AstraZeneca
Genetic Toxicology - George Johnson, Swansea University
Carcinogenicity - Nigel Roome, Consultant
Clinical Pathology - Jo Harding & Peter Cotton, AstraZeneca
Pathology - Vasanthi Mowat, Envigo
Reproduction/Developmental Toxicology - Alan Hoberman, Reproductive and Juvenile Toxicology
Immunotoxicology - Marc Pallardy, University Paris-Sud
Safety of Biotechnology Products - Mary McFarlane, MedImmune
Risk Assessment - Ernie Harpur, Newcastle University
Regulatory Toxicology - David Jones, MHRA
Regulatory Case Studies - Kenneth Hastings, Hastings Toxicology Consulting, LLC
Breakout Group Discussion of Nonclinical Assessment of Drug E with Regulators - Kenneth Hastings, Hastings Toxicology Consulting, Tanya Chambers, MHRA and Michelle Beharry, DLRC Ltd
Review of Nonclinical Assessment of Drug E: A Regulatory Perspective - Kenneth Hastings, Hastings Toxicology Consulting, LLC
Timings
Monday: 08.00 - 19.00hrs (includes reception* from 17.00 - 19.00hrs)
Tuesday-Thursday: 08.30 - 17.00hrs
Friday: 09.00 - 12.00 noon
* There will be a reception with hors d'oeuvres and drinks following the course on Monday which is included in the registration fee. Please join us and meet your fellow attendees, course organisers and speakers to interact and network in a casual relaxed atmosphere.
Course Organisers
Ernie Harpur, Newcastle University
Hanan Ghantous, US Food and Drug Administration
Norman Kim, Roivant Sciences
Registration
|
Early Bird Before 22nd June |
|
Late After 22nd June |
Individual |
£ |
|
£ |
ACT and BTS Member Registration |
795.00 |
|
950.00 |
Student (Full Time) Registration |
795.00 |
|
950.00 |
Government Registration |
795.00 |
|
950.00 |
Non-Member Registration |
1,025.00 |
|
1,180.00 |
Group (Contact meetings@thebts.org for further information) |
|
|
|
Member Group Rate (3 or more from same company) |
680.00 |
|
835.00 |
Non-Member Group Rate (3 or more from same company) |
910.00 |
|
1,065.00 |
Note: Payments will be processed in GBP £Refund PolicyCancellations will be accepted according to the terms below and should be sent in writing to meetings@thebts.org
Cancellations up to 1 June 2018 - Full refund less £75 administration fee
Cancellations between 1-22 June 2018 - Full refund less 50% cancellation fee
Cancellations after 22 June 2018 - No refundLocationThe Møller Centre
Churchill College, Storey's Way
Cambridge, Cambridgshire CB3 0DE
United Kingdom
www.mollercentre.co.uk
The Møller Centre offers en-suite bedroom accommodation. Participants of the PATDD course are being offered a special single occupancy rate of £134.40 (incl VAT) per night or £158.40 (incl VAT) for double or twin occupancy
If you wish to stay at the Møller Centre, you can book this as part of the online registration process prior to Friday 22nd June.
Payment will be required prior to arrival this year but you will be provided with the option of paying your registration and accommodation at seperate times.
Confirmation of your full booking will be sent to the email provided.
Note: The PATDD Course's allocation of accommodation has now been taken. Please contact the Moller Centre on +44 (0) 1223 465500 to check availability.
Questions regarding accommodation should be addressed to the course Event Manager on meetings@thebts.org.
Requirements
A personal laptop to view course materials and your computer charger is required.
Access to the PATDD course material will be provided approximately one week before the start of the course.
A course app will also be available for you to access course material required during the week however it is recommended that you also download the course materials to your laptop prior to your arrival.
NOTE: You will still require access to the app during the week to participate in the course surveys and Q&A's.