When: 10 September | 16:00 – 17:30 CEST (GMT+2)
The ICH S11 guideline which was recently finalised is an important document that provide direction on the nonclinical safety studies important to support a paediatric development programme. It recommends standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provides guidance on the design of the studies. A streamlined drug development and higher scientific rigor while minimizing the unnecessary use of animals is expected to be achieved with the implementation of this new harmonised ICH guideline. While the ICH S9 guideline should be consulted for recommendations on whether to conduct a JAS for anticancer pharmaceuticals, the ICH S11 guideline should be consulted for study design in all cases, including oncology indications.
Paediatric development is high on the ICH agenda, since in addition to the S11 guideline, the E11 paediatric was revisited and the E11A paediatric extrapolation is currently being drafted.
Agenda:
1. Introduction to TOPRA in France by Gabriel Bohl
2. David Jones and Luc De Schaepdrijver presentations – 30 min each. During the session, they will be exploring:
- Considerations for additional nonclinical safety investigations
- Design of nonclinical JASs
- Considerations for paediatric-first/only development
- Data interpretation
- Other considerations, eg excipients, fixed combination medicinal products
- Case examples
3. Q&A – for the remainder of the webinar
Speakers
Dr David Jones
After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, David Jones currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London, UK.
His current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological. A further aspect of his job is to offer regulatory advice to companies on behalf of the MHRA or the EU’s Committee for Human Medicinal Products (CHMP). David is one of the UK’s accredited non-clinical experts to support the CHMP and is the UK representative on the EU’s Safety Working Party (SWP). He represented the EU in the ICH revision of the M3 Guideline and on the new ICH S11 Guideline.
David is also a guest lecturer at the University of Surrey and the University of Wales and a frequent presenter at conferences around the world.
Dr Luc De Schaepdrijver
Luc joined Janssen R&D in 1992 as Study Director, Reproduction Toxicology and since then has held various positions of increasing responsibility. He is currently Scientific Director, Fellow in the Department of Nonclinical Safety, Janssen R&D and has an expert function in reproductive / juvenile toxicology. He is the global head of the DART- Preclinical Paediatric Team in his company and is the expert for EFPIA on the ICH S11 guidance.
Pricing
- Members: free
- Non-members: £45 - includes two months of trial membership
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