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Zoran Simic,

As a Medical Director, Zoran is responsible for providing input and critical review of the clinical sections of a variety of documents for regulatory submissions. He plays a key role in reviewing clinical development plans and identifying Scientific Advice questions for regulators and joint regulator-HTA bodies. Zoran also provides expertise in responding to the issues raised by regulators during the assessment of applications and participates in the preparations for client presentations and for oral explanations.

Zoran brings to this role extensive experience across various therapeutic areas of medicine and disease prevention such as neurology and psychiatry, rare diseases, infectious diseases, and vaccines. He has worked in all phases of clinical development, including running clinical trial sites.

Prior to joining VCLS, Zoran spent over 10 years at the MHRA working as a Senior Medical Assessor and as the Biologicals and Biotechnology Unit Manager.  Zoran has significant expertise in the assessment of Orphan Drug Designation, EMA Scientific Advice, early access pathways and Marketing Authorisation Applications (including ORBIS and ILAP projects) from medical aspects at UK MHRA and EMA. His experience also covers the oversight of scientific guidelines and procedures (such as for Advanced Therapies, Biosimilars, Post-Brexit regulatory pathways and Expedited rolling review of emergency medicinal products) and authoring papers for expert advisory groups.

He made regular presentations to the Committee for Medicinal Products for Human Use (CHMP) and Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh). He held observer positions at Central Nervous System Working Party (CNSWP) and Scientific Advice Working party (SAWP) contributing to development of EMA guidelines for industry (e.g. for investigation of Alzheimer’s disease, schizophrenia and depression). Zoran also held the position of principal assessor for the Clinical Trials, Biologicals and Vaccines Expert Working Group (CTBVEAG) of the CHM.

Zoran qualified as a Medical Doctor from the University of Tuzla (Bosnia and Herzegovina) and he is Fellow of Faculty of Pharmaceutical Medicine of Royal College of Physicians (UK), Member of Royal College of Psychiatrists (UK) and International Fellow of American Psychiatric Association (US). He holds Master of Science degrees in Pharmacology, Translational Medicine and Information Systems Design and diplomas in Pharmaceutical Medicine and in Chronopharmacology.

Zoran Simic
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