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Currently eight of the ESR's in PEARRL are completing a secondment at one the Regulatory Partners organisation in PEARRL.
Huge thanks to all our Regulatory partners for organizing these secondments. Special thanks to Jobst Limberg (BfARM), Evangelos Kotzagiorgis (EMA), Sean Jones (MHRA and Una Moore (HPRA) as the coordinators of these regulatory-academia collaborations Dr. Rodrigo Chrisfoletti, Division of Therapeutic Equivalence, Brazilian Health Surveillance Agency (ANVISA), presents a research presentation entitled 'Going beyond the traditional BE borders: using in vitro and in silico tools to improve the assessment and extrapolation of therapeutic equivalence'
The Academy of Pharmaceutical Sciences is hosting a joint meeting of Biopharmaceutics and Regulatory Science in London in November 2017. The focus of the workshop is on 'Developing Clinically Relevant Dissolution Specifications for Oral Drug Products - Industrial and Regulatory Perspectives'. A very interesting programme is planned. For further info see https://www.apsgb.co.uk/Events/20171107/Default.asp
As an integral part of PEARRL’s Open Access strategy, the ESRs have created the InfoPEARRLs. The InfoPEARRLs introduce the ESRs and their respective research in the form of a short video. These videos are available right here on the PEARRL website or on PEARRL’s own youtube channel, PEARRL Network.
Daniel Price, one of PEARRL’s Early Stage Researchers has published his first scientific paper as lead author in Chemical Communications this month entitled “Poly(amino acid)-polyester graft copolymer nanoparticles for the acid-mediated release of doxorubicin”. This research was carried out at the School of Chemistry, University of Leeds, before Daniel joined Merck and the PEARRL project for his PhD studies.
An open symposium on ‘Regulatory Support of Innovation in the Pharmaceutical Industry' on 21st June 2017 as part of the first Annual PEARRLS of Wisdom Week in Cork, Ireland http://www.pearrl.eu/rss2017.html. PEARRL is a European Training Network (ETN) that brings together partners from European pharmaceutical industry, academia and regulatory agencies as a multi-sectorial team to deliver collaborative research and training network focused on accelerating the development and approval of breakthrough therapy drugs.
Written by Niklas Köhl (ESR 1) & Felix Ditzinger (ESR 2)
As the first PEARRL Early Stage Researchers we had the exceptional opportunity of getting three months first-hand experience on the regulatory working procedures within the Health Products Regulatory Authority (HPRA) in Dublin. |
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