Giorgos Panoutsopoulos

- Lifecycle management of authorized products through timely preparation and submission of transfer, variation and/or renewal application dossiers - Good understanding of legislation, policies and procedures for pricing and reimbursement - HTA application dossiers compilation (Budget Impact, Costs & Economic evaluation, Markov models) - Single pharmacovigilance contact point for the competent authorities and the EMA - Establishment and maintainance of corporate pharmacovigilance system (PSMF)

• Ensure timely preparation, submission and follow-up of new Marketing Authorization, Variations, Renewals and Transfer of MAH applications (National, MRP, DCP) • Prepare module 1.3 (PI texts) and module 1.8.2 (RMP) of the dossier • Work alongside the BD, Sales & Marketing department to support business initiatives • Manage the implementation of pricing and reimbursement strategy in collaboration with the Business, Marketing & Sales Dpts, in line with HQs’ guidance • Act as medical information liason

• Preparation and submission of applications through National, MRP & DCP • Monitoring the progress of applications against set timelines and liase with NCA where necessary • Module 1 compilation (Product Information and Risk Management Plan) • PhV submissions (PSUR, RMP) • Regulatory compliance of packaging materials • Regulatory compliance of the promotional materials • Handling medical information queries • Following, analysing and implementing national legislation on pricing and or reimbursement

- Regulatory Affairs and PharmacoVigilance for Pharmaceuticals, Nutraceuticals, Food supplements and Medical devices - Responsible Person (QP) for labeling procedure (IPCs and batch release) for pharmaceutical products - Scientific Manager for Nutraceuticals, Food supplements, Medical devices. - Quality Manager for ISO 9001:2008 (Pharmaceuticals, Food Supplements, Medical Devices) (2010-2012)

- Extraction, isolation and identification of secondary metabolites from medicinal and aromatic plants. - HPLC, MPLC, VLC, TLC, p-TLC, NMR, 1D & 2D, Mass Spectroscopy techniques.

Health Economics and Administration

Pharmacognosy and Chemistry of Natural Products

Pharmacognosy and Chemistry of Natural Products

Pharmaceutical Science