Archives: Speakers

Extensive expertise in EMC and Safety Design for Medical Devices, Risk Management and Process Development, Regulatory strategy planning and execution for US, EU and global markets.
Experience in CT, MR, Ultrasound, EP imaging, Interventional Catheters, Mammo, Molecular imaging.
Outstanding success in developing and implementing globally compliant Quality Management Systems for independent and corporate environment activity. Business partner

Hadar owns B.Sc. in Chemical engineering From BGU (Ben-Gurion University of the Negev) & B.Sc. in Polymer engineering from Shankar College of Engineering experienced in leading R&D projects in Biopharmaceutical companies.

Worked in Perrigo API performing commercial procurement for the API division, joined Teva in 2011 as Senior procurement manager in R&D performing global procurement.

Since joining Clinical Supply Chain group,  within TEVA’s R&D global clinical operations in 2018, Hadar been leading clinical supply chain projects within verity of programs and TAs, each one includes multiple clinical trials in different clinical phases, identifying unique challenges and tailoring the project planning accordingly with ongoing risk management in accordance with international guidelines and regulations.

She holds various responsibilities including plan efficient drug product demands, coordinating the manufacturing with CMC in all TEVA’s manufacturing plants, sourcing of comparators, plan and design the clinical drug packaging and labeling, Design IRT/RTSM system, set-up and oversee maintenance and overall ensure timely delivery within specifications, quality and standards.

Hadar initiated and led new approach for P&L at Teva, and manage the first large scale ‘Direct to patient’ (DTP) study, implement also new IRT system to support it.

Michal Klein,  B Pharm , MHA ,   Quality Unit Manager and QP at Roche Israel , Experienced Quality Assurance Manager with a demonstrated history of working in the Pharmaceutical industry and as a GMP/GDP inspector of the  Israeli Ministry of Health Institute for Standardization and Control of Pharmaceuticals

• Clinical trials:
• Coordination of Clinical Trial Material / Investigational Product supply to clinical sites according to Local legislation, Sponsor’s SOP and GCP / GDP / GMP
• Coordination of Clinical Trial Material / Investigational Product use on clinical trial sites according to Local legislation, site’s SOP and GCP
• Training of clinical / pharmacy personal on all aspects of drug accountability (including preparation of treatment)
• Training of clinical personal on use of medical devices (when applicable)
• Quality control:
• QC laboratory team leadership
• Organization of QC laboratory according to GMP
• Planning and execution of Development and Validation of Analytical and Biochemical methods according to GMP, USP and PhEur
• Auditing of QC laboratory methods and results
• Preparation of regulatory required documents according to GMP (SOP, methods, reports…)

Aurélie Schwarzbach has over 15 years of experience in the clinical research field. She is currently a senior project manager at Gamida Cell, a Jerusalem-based company, that she joined 7 years ago. She has been managing several clinical activities in studies of different phases, mainly Phase I-II and Phase III studies. More recently, she has orchestrated the clinical activities and documents preparation for the submission of a Biologics License Application (BLA) for omidubicel, an advanced cell therapy of Gamida Cell advanced cell therapies (www.gamida-cell.com).

Dina Kofler has been with Medinol since 2013. As VP Clinical Affairs, she leads the clinical department and manages all clinical trial activities including the pivotal trials that constituted the clinical basis for the EluNIR DES’ approval in the United States, Europe and Israel. Before joining Medinol, Dina worked at MediWound Ltd. and prior to that she worked for 14 years at Teva Pharmaceutical Industries Ltd and held various clinical-trial management positions. She holds B.Sc. in Biology from the Tel Aviv University and an MBA from the Herriot-Watt University’s Edinburgh Business School.