More than 10 years working with BASF AG, Ludwigshafen. Responsible plant engineer for cGMP compliant biotech and chemical API production plants. Chairman of BASF’s GMP committee. Active member of DIN standardization institute and DECHEMA (organizer of Achemasia) focusing on GMP relevant biotech processes and validation. Involved in the development of the PIC/S document PI 006 (validation) and of the ICH Q7 GMP guideline for APIs. Post- BASF working over 4 years with DIS AG as head of a newly installed GMP consulting division. Since 2002 managing director of gempex – an EU based GMP service providing company - and of gemro, the Asian representative of gempex.

Today 20 plus years experience in all GMP matters focusing on EU / US GMP compliant biotechnological, chemical and pharmaceutical manufacturing plants. Involved in audit execution, preparation of and assistance during FDA / EMA inspections, GMP trainings and regulatory affairs consultancy (CEP, ASMF, DMF). Still active in many national and international associations (ISPE, PDA, BAH, VIP3000, etc.). Permanent speaker on international seminars and congresses. Author of several scientific journals. Beyond others he has published a unique book about “GMP, Qualification & Validation of API plants”.

Until 2001 working in the US pharmaceutical industry with companies like Pfizer Inc., Carter Wallace Inc., Banner Pharmacaps Inc., Workhardt Americas Inc., and Duramed Pharmaceuticals Inc. (a Barr company). Mostly in the position of a Manager of Production, Director of Technical Services and Regulatory Affairs, later as Corporate Vice President Technical Affairs. Since 2002 president and founder of IRB Consultants, L.L.C., N.Y.

Over 40 years in the field of GMP. From 1973 starting close cooperation with US FDA by being a selected expert member in many working groups focusing on topics like: establishment of OTC drug review and drug listing programs, development of validation standards, establishment of nutritional supplement GMPs, developing SUPAC-IR, and BACPAC guidelines, discussing gelatine BSE problems, and many more. Still a member of PhRMA, CHPA, and different FDA working groups. Published more than 30 papers on GMP, and validation. Auditor and Co-auditor of several textbooks. Today working closely with gemro as US representative, giving trainings, consultancy, and coordinating all relevant activities with US FDA, e.g. DMF filing.

Until 1999 owner of a pharmacy with manufacturing licence for drug products. Acting as Qualified Person (QP) according European law and being a honorary GMP inspector. From 2002 to 2006 joining CONCEPT Heidelberg, the most famous GMP training and consultancy company in Europe, working as a project manager, specialized in GMP for APIs (Active Pharmaceutical Ingredients) and Regulatory Affairs. Currently, Barbara is Managing Director of PhACT (Pharmaceutical Advice , Compliance & Training specialized in Drug Regulatory Affairs) GmbH, closely cooperating with gemro for direct filing ASMFs to EMA and CEPs to EDQM, doing the expert review, and the communication with the authority.

Barbara has more than 18 years experience in the European Regulatory Affairs field. Beyond others she worked as an external assessor of the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany. She is co-author and co-editor of the Guide to Drug Regulatory Affairs, published by Editio Cantor Verlag, Aulendorf, Germany. In 2007 she has been appointed as lecturer at ETH (Swiss Federal Institute of Technology) Zurich, Switzerland within the pharmaceutical Master Education. Since 2008 she chairs PDAs European Interest Group “Inspection Trends and Regulatory Affairs”.

Started professional career as head of the engineering department of Gilan Regional, Iran. Since 1992 working for several pharmaceutical engineering and service providing companies like PhC – Pharma Consult GmbH, Heidelberg, PIC GmbH, Pharmaplan Heidelberg, and others. Since 2002 working as senior GMP expert and APIC certified 3rd party auditor mainly in the Asian region.

Mohsen has nearly 20 years of GMP experience. He was deeply involved in the design, the planning, and construction of GMP compliant API and final pharmaceutical production plants. This includes, but is not limited to, projects for liquid, semisolid, and solid dosage forms of medicines as well as projects for sterile products. He was the project manager for a huge vitamine project in Asia responsible for the full GMP implementation and finally for the GMP certification by international bodies. Today he is focusing on 3rd party audits, GMP compliance consultancy and is head of the gempex GMP training center.

Start of professional career in the chemical and related industry working for several years on the development and analysis of chemical pathways and procedures mainly with the focus on the production of life science products. Since 2001 in deep consideration of GMP relevant processes and products.

Joono has 10 plus years of experience in GMP and GMP related processes. She actively worked on numerous Chinese GMP projects doing trainings and consultancy on topics like risk assessment, SOP preparation and handling, qualification and validation, and many more. She guided many western auditors doing GMP compliance audits and executes 3rd party audits by herself. She is expert in Chinese and western (EU/ US) GMP guidelines respectively and also is involved in CEP/ ASMF/ DMF preparation and filing. She gave several trainings and lectures directly for pharmaceutical companies as well as during public seminars.

Starting 1999 in the Hong Kong Institute of Biotechnology Phoebe mainly concentrating on GMP relevant projects, providing technical support and GMP consultation to Hong Kong based pharmaceutical companies. Giving training to operators on topics like warehouse and packaging operation, production procedures, documentation and many more. Was involved in the TGA cGMP certification process giving the necessary consultation and support for inspection preparation. From 2001 engaged at Seerpharma Pty Ltd., Singapore as a GMP consultant for GMP compliance, quality assurance, validation and training projects. Today is working as senior GMP expert in the gemro’s joint venture.

Having 10 plus years of experience Phoebe is a senior expert in international GMP regulation and topics like GMP compliant operation, process and cleaning validation, production documentation, site master file preparation, GMP trainings, and many more. She is familiar with all of the GMP compliance requirements.

Starting his professional career at Mentholatum Pharmaceutical Co., Ltd. as a Senior Registration Officer being responsible for the domestic registration, including several import drug registrations and new drug applications. In 2003, he joined Chongqing Holley Holding Company as a registration manager and product manager, being responsible for the international registration of anti-malaria drugs, the preparation of DMFs, and the preparation of on-site audits. Since 2006 working as a Project Manager and Senior GMP expert for gemro services Ltd.

Rick has more than 12 years experience in international GMP regulation. He already has managed many API and final pharmaceutical projects with focus on international, mainly EU and US GMP compliance. Giving training, working on qualification and validation topics as well as on risk assessment projects. Assistance of 3rd party audits executed by gemro or by western companies. He guided Chinese manufacturer when upgrading their GMP system to western standards. He also is experienced in all questions concerning CEP, DMF, and ASMA respectively. He already has given a lot of public speeches and presentations on GMP topics.

Starting her professional career in 1998 Cobby worked for several international oriented companies being responsible for marketing research, customer evaluation, and product adaptation and optimization based on the research results. She has very good skills regarding the knowledge of chemical and pharmaceutical production processes and the way on how to find and attract potential customers in the international commerce.

Cobby joint gemro right from beginning and now has GMP relevant experience for about 5 years. She knows the problems of Chinese API and pharmaceutical manufacturers to comply with western GMP standards. She is analyzing the individual problems, identifying the customer’s specific needs and doing the communication and contacting to the gemro’s GMP experts.