Surendra Gokhale

Company: Roche
Surendra

Dr. Surendra Gokhale is currently Senior Group Manager in the Global Regulatory Affairs in Roche Basel, having joined Roche Basel in research in 1990. He moved to regulatory affairs in 1995 and has worked as Global Regulatory Leader on several projects in different therapeutic areas.

He is currently heading the EU/International Clinical Trials regulatory management group at Roche head office in Basel. Global approach for the clinical development keeping in mind the GCP concept and the patient in focus is the main goal of his work. Working for the innovative Industry, finding the alignment between different regional regulatory aspects in the EU, US, Asia and Latin American countries and Global development plans is the main focus of his work.

As part of Roche Global Regulatory affairs, since 2008 Dr. Gokhale is Roche representative on the Regulatory Affairs group [ERLC], EU Clinical Trials subgroup, of the European Pharmaceutical association [EFPIA]. He was member of the EFPIA in the ICH M5 subgroup. Since mid-2014 he is the EFPIA Topic leader on the ICH E6 [R2] group dealing with the GCP guideline update. He also represents Roche in the IFPMA Regulatory group [RPTS].

After basic education in organic medicinal Chemistry at Pune, India; he has worked as research scientist with Ciba-Geigy in the area of tropical diseases, and spent 15 months at University of Konstanz, Germany where he worked in the area of Oligonucleotide Synthesis and model studies towards the automated synthesis of tRNAs. At Roche Basel he had spent further 5 years in basic Research and has worked in the several disease areas including development and successful launch of the first HIV protease Inhibitor.