Speakers from Industry
Dr Johanna Eisele, Evonik Industries AG, Germany
Dr. Johanna Eisele is Head of Regulatory Affairs, Pharma Polymers, an Evonik business line that manufactures acrylic copolymers for use in oral and dermal dosage forms. Amongst other duties her responsibility includes negotiation of quality agreements with pharmaceutical customers and introducing such agreements into the supply chain with the distributors of Pharma polymer products. Dr Johanna Eisele represents Evonik Industries at the IPEC Europe.
Ralf Gengenbach, gempex, Germany
Mr Gengenbach is founder and managing director of gempex Co. Ltd., Germany. He is member of different organisations, among others DIN UA2 (Board for standards ‘biotechnology’), of DECHEMA and ISPE. He is approved Quality Auditor according to DIN ISO 9000ff..
Dr Martin Melzer, Chemgineering Business Design GmbH, Germany
Dr Martin Melzer is Senior Consultant GMP Compliance. Before that he was GMP -Inspector in a German Field Inspectorate in Hannover. During that time he was representing the German inspectorates in EMA and PIC/S Working Groups for the preparation of the new GDP-Guidelines. He was heading the GDP Expert Group of the German GMP inspectors from 2008 up to 2011. Before that he was working at Solvay Pharmaceuticals GmbH and a company of the Diapharm Group.
Dr Bernd Renger, Bernd Renger Consulting, Germany
Dr Bernd Renger is a member of the ECA Advisory Board and was Chairman of the European QP Association. Since 2011 he is running his own consultancy business. Before that he was VP of Quality Control at Vetter Pharma-Fertigung. He started his career at Hoechst AG as a research and development chemist. Since then, he has held several quality management positions at Mundipharma, Altana Pharma and Baxter BioScience.
Speaker from Authority
Rico Schulze, GMP Inspectorate, Local Authorities Dresden, Germany Rico Schulze is a Pharmacist and holds a degree in Economics. Since 2003, he is GMP and GDP Inspector at the Local Inspectorate in Dresden. From 2008 to 2011 he was working at the Saxon State Ministry of Social Affairs. He is also the Head of the German Authorities’ Radiopharmaceuticals Working Group.