DATE AND TIME: Wednesday 30 November 2022, 16:00-17:30 CET - Check local times
Selecting excipients with appropriate safety and tolerability is a major hurdle in paediatric formulation development as the dynamic developmental physiology of children differs considerably to an adult. Within the paediatric regulatory context, the final evaluation on the acceptability of an excipient in a product should be based on an overall risk to benefit evaluation. This drives a need for a systematic approach to selection and risk assessment of excipients. A Paediatric Excipients Risk Assessment (PERA) framework has been developed by EuPFI in collaboration with IQ consortium ped working group. It is a structured, systematic decision-making tool to selection of excipients and can contribute to the quality and safety of paediatric patients when used effectively. The webinar will be focussed on the introduction to the PERA framework and tool. Practical formulation case-scenarios will be presented to illustrate the use of Benefit/Risk Approach Metrics for selection of excipients for paediatrics.
PRESENTERS
Dr Smita Salunke, Chief Scientific Officer, European Paediatric Formulation Initiative (EuPFI) and Research associate, UCL, United Kingdom
Dr Smita Salunke is the Chief Scientific Officer of European Paediatric Formulation Initiative (EuPFI) and research associate at UCL. She has a formulation science background and her experience as a researcher goes back more than a decade with extensive knowledge in product development of oral solid and liquid dosage forms, project management, product and services management, both from industry and academia. She was the visiting expert at the European Medicines Agency (EMA). Her significant contribution to the field of pharmaceutical excipients and scientific community is the creation of the STEP (Safety and Toxicity of Excipients for Paediatrics) database, evident through the users around the world (more than 3000; 44 countries; 6 continents). Her current research is focused on biopharmaceutics and understanding the excipients activity in children motivated by a deep desire to address the issues and questions encountered by the industry, hospitals and government on acceptability of excipients in paediatric formulations. She is also working on administration devices for children and co-creating wise solutions to global challenges and problems associated with formulating medicines for children in low resource settings. She is the founder of Paediatric Medicines Healthcare Initiative (PMHI), non-profit organisation in India which aims to stimulate the paediatric formulation research in India.
Dr Anjali Agrawal, Executive Director, Head of Drug Product Development and Manufacturing, Forma Therapeutics, USA
Anjali is a head of drug product development and manufacturing at Forma Therapeutics. She is a strategic Pharmaceutical Executive with more than 20 years’ experience in discovery support, pre-formulation, formulation/process development, scale up and technical transfer that enabled clinical studies and commercialization of oral and parenteral drug products for NCE’s, pediatrics, and product line extension. She successfully established formulation development groups at BMS, Celgene, Boehringer Ingelheim, Pfizer, and Wyeth by promoting “One Team” culture that enabled approval of innovative products and portfolio enhancement. Anjali broadened her impact on drug development by taking up leadership roles in global project management, CMC project management, and alliance management. She is an innovative thought leader with a history of success in designing novel processes, platform formulations, and material sparing predictive methodologies that streamlined DP development and accelerated commercialization of innovative medicines. She has a passion to develop palatable pediatric dosage form and established enterprise strategy as well as led development of oral and parenteral pediatric products. She is an active member of AAPS, IQ Pediatric, EuPFI, and PHMI consortia.
REGISTRATION FEES
IPEC Europe Members / EuPFI Members / IQ Consortium Members: 60 €
General Admission: 80 €
Students: Free of charge
All fees VAT excl. Students must be enrolled in a University to benefit from the discount.
