Dr Flavio De Rosa founder of Paracelsus Science GmbH, has more than 30 years of drug development industry experience in all phases of drug development covering diverse therapeutic areas, including oncology, rheumatology and infectiology, and with diverse responsibilities - from drug safety analyses, to advising senior management to study design and conduct.
Academically trained (PhD, MSc. Diploma in Pharmaceutical Medicine) with extensive "hands on" experience in medium and large pharma companies and in a specialised CRO, Dr De Rosa has a broad knowledge of the industry and of medicine and experience working with Key Opinion Leaders. With considerable Clinical Scientist experience in the US, Europe and Australasia (Australia, Malaysia, Japan) he has successfully and consistently delivered complex projects and analyses within set timeframes, budgets and to a very high standard. About Paracelsus Science GmbH;
Paracelsus Science was set up in 2017 to offer support to companies requiring senior specialised staff on a one-off, short- and medium-term basis.
The aim of this webinar is to provide an introductory overview of the requirements demanded by the FDA and EMA (arguably the two most important regulatory authorities for drug developers) for EIM (the IND and IMPD) and to provide an brief review of where the agencies differ as well the commonalities of approach for their EIM dossiers.