Preclinical safety assessment of a potential drug represents an essential part of its development process. The low success rate of development programmes has caused an intensification and expansion of the field of safety science, towards a much more integrated view of safety from early discovery to post-marketing safety monitoring. This first course allows to gain a deeper insight in:
regulatory requirements for studies used in preclinical safety assessment;
preclinical testing of candidate drugs to demonstrate potential harmful effects;
risk/benefit assessment of drugs profiling;
safety aspects integration in the overall risk assessment for selection of drug candidates;
calculation of the maximum recommended starting dose in FIH trial based on the preclinical studies and strategies for preclinical development.
This course is designed for drug R&D professionals who wish to develop their skills and knowledge in preclinical safety.
The training panel includes leading scientists in the pharmaceutical industry and preclinical CROs and consultancies.
PALAU MACAYA
Pg. de Sant Joan, 108, 08037 Barcelona
https://goo.gl/maps/77BD6TMjNSbF1f3X6
REGISTRATION
www.annionpharma.com/events/preclinical-safety
REGISTRATION FEES
725€ (+ 21%IVA)
10% discount if you register before 15/1/23 - use EARLYBID10 code.
10% discount for 2 or more delegates - use GROUP10 code
15% discount for CataloniaBio & HealthTech members - use your discount code.
Includes coffee break, lunch and documentation
Organized by Annion Pharma
Sponsored by Labcorp and BioTrial
9AM Registration
9.30AM Welcome - Day´s Proceedings - Ana Gavaldà, PhD (Founder & Managing Partner at Annion)
9.35AM Overview- Challenges and Opportunities - Raquel Bou, ERT (Managing Partner & Toxicology Consultant at Annion)
PRECLINICAL SAFETY IN DRUG DEVELOPMENT
9.50AM Preclinical Studies Overview for Drug Development - Marisa Vinyals, PhD (Preclinical Safety Expert at Almirall)
10.30AM Discovery Toxicology Challenges. Genotoxicity - Mariona Aulí, PhD, ERT (Preclinical Safety Leader at Almirall)
11AM Safety Pharmacology - Christophe Drieu la Rochelle, PhD (Head of Preclinical at Biotrial)
Coffee - Networking 11.40AM
12PM General Toxicity Studies - Lindsey Parkinson, BSc PhD CPM (Associate Drug Development Leader)
12:40PM Reprotoxicity - Daphne van den Oetelaarm (Study Director Developmental and Reproductive Toxicology at Charles River Laboratories)
1.20PM Carcinogenicity and Immunotoxicity - Professor Paul Baldrick, PhD (Executive Director, Nonclinical Regulatory Strategy, Product Development and Market Access Consulting, Labcorp)
Lunch 2PM
PRECLINICAL SAFETY: SUPPORTING ACTIVITIES
3PM Regulatory perspective - Mariana Gómez-Ferreria, PhD (Regulatory Sciences Associate Director at ProPharma Group)
3.40PM Toxicology and Safety Data for product handling (CMO, production) - Raquel Bou, ERT (Toxicology Consultant at Annion) & Begoña López, ERT (EHS Chem. & Toxicol. Risk Manager at Esteve Pharmaceuticals)
4.20PM Round table: startup experience, challenges - Mercè de Frias, PhD (Chief Operating Officer at Ona Therapeutics), José Alfon, PhD (VP, Research & Development at Ability Pharmaceuticals), Pilar Pizcueta, PhD (Director of Biology at Minoryx Therapeutics), Maribel Bergés (Chief Executive Officer at Affirma Biotech S.L). Table moderated by Mridvika Narda, PhD.
If you prefer to pay by bank transfer please contact us at info@annionpharma.com
