Educational Courses
Practical Application of Toxicology in Drug Development
Co-Sponsored with Charles River and in association with the British Toxicology Society
Course Description
This course, taught by distinguished experts, is designed to provide a basic training in toxicology. Participants will obtain an overall understanding of the principles of nonclinical safety evaluation with emphasis on the practical application of these principles and interpretation of nonclinical safety data. The course will include discussion of regulatory case studies and a workshop. This toxicology course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, along with those from Contract Research Organizations and regulatory agencies who are interested in toxicology. Regulatory toxicology in drug development will be emphasized, particularly from the European perspective.
Course Schedule
Monday, September 15
Basic Principles of Toxicology, A. Wallace Hayes, Harvard
Pharmacology, Rob Wallis, Safety Pharmacology Consultant
Safety Pharmacology, Rob Wallis, Safety Pharmacology Consultant
Toxicology Methods/General Tox, Adam Woolley, ForthTox
Regulatory Toxicology, David Jones, MHRA
Tuesday, September 16
Organ Systems, John Foster, Senior Consultant Pathologist
Clinical Pathology, Malcolm York, GlaxoSmithKline
Pathology, Peter Greaves, MRC Toxicology Unit
Wednesday, September 17
Reproduction/Developmental Toxicology, Gary Chellman, Charles River
Pharmacokinetics/ADME, Gerry Kenna, Safety Science Consultant
Genetic Toxicology, George Johnson, Swansea University
Carcinogenicity, Nigel Roome, Sanofi
Thursday, September 18
Safety of Biotechnology Products, Jennifer Sims, Integrated Biologics
Immunotoxicology, Ian Kimber, University of Manchester
Risk Assessment, Ernie Harpur, Newcastle University
Regulatory Case Studies
Kenneth Hastings, Sanofi US
Friday, September 19
Nonclinical Assessment of Drug A:
A Special Workshop of Drug Development from Regulatory Perspective
Kenneth Hastings, Sanofi US
Jennifer Sims, Integrated Biologics
Times:
Monday through Thursday 8:00 AM–5:00 PM
Friday 8:00 AM–12:00 Noon
Program Committee:
Ernie Harpur, Newcastle University
Hanan Ghantous, US FDA
Norman Kim, Biogen Idec
Organizers:
Karen McCusker, Charles River
Jamie Wilton, Charles River
Registration
Space is limited to 60 attendees—register early
| By September 12 | |
| ACT and BTS Member Registration |
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| Nonmember Registration |
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| Government Registration |
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| Student (Full Time) Registration |
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| Group Nonmember Registration (Three or More from Same Organization*) |
|
| Group Member Registration (Three or More from Same Organization*) |
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* In order to take advantage of this discounted rate, registration form(s) should be returned to ACT Headquarters for processing.
Note: Payments will be processed in US $.
Refund Policy:
- £50 Processing Fee will be charged before June 28, 2013.
- 50% refund if canceled before July 26, 2013.
- After July 26, 2013, no fees will be refunded.
Location
The course is held at:
Crowne Plaza Edinburgh
The Roxburghe
38 Charlotte Square
Edinburgh EH2 4HQ
United Kingdom
+44 (0)844.879.9063
www.theroxburghe.com
For lodging, make arrangements directly with the hotel above, mentioning that you are participating in the course.
Housing Deadline: Friday, August 15
Alternative Housing Options
Premier Inn, Edinburgh Princes Street
Distance: 0.1 miles
Travelodge Edinburgh Central Princess Street Hotel
Distance: 0.4 miles
Travelodge Edinburgh Central Queen Street Hotel
Distance: 0.4 miles
Mercure, Edinburgh City
Distance: 0.5 miles
Holiday Inn Express, Edinburgh City Centre
Distance: 1.0 mile
Tel: 703.547.0875 | Fax: 703.438.3113 | Email: acthq@actox.org
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