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Business talk between several persons

Interactive workshop focused on Advanced Therapy Medical Products (ATMP), 27-28th of September 2018.

The International Association for Pharmaceutical Process Engineering e.V. (APV) offers an interactive ATMP workshop on "Bridging standard pharma concepts and ATMP" in Vienna from 27-28th of September 2018. Dr. Hans-Georg Eckert, Senior Project Manager and GMP Consultant at Valicare GmbH, is significantly involved in the organization of the event. He is a member of the APV and has a deep knowledge and many years of experience in the development, approval and production of ATMPs.

Development and commercialization, current and future regulatory requirements, clinical studies, critical aspects of raw material, process design and automation are only some of the keywords of the exciting lecture topics scheduled for the ATMP workshop.

The exchange of experiences regarding strategic planning and pharmaceutical development of ATMPS for market access will also take place in interactive discussion rounds in the afternoon of the first day.


GMP-compliant qualification, in-house training, 12th of June 2018 and 23th of October 2018

If you would like to learn more about the procedures and regulatory requirements of risk-based and GMP-compliant qualification, contact our GMP experts or attend one of our GMP training courses. Although our internal training courses are primarily intended for the qualification of our employees, we are pleased to welcome external visitors. Participation is free of charge but place is limited.


GMP for ATMPs in-house training, 15th of November 2018

If you have any questions about ATMPs and would like to learn more about the GMP for ATMPs guideline published by the EMA at 22th of November 2017, contact our ATMP experts or take part in one of our GMP for ATMPs training courses, planned at our site in Frankfurt on 15th of November 2018. Although the training is primarily intended for the qualification of our employees, we are pleased to welcome external visitors. Participation is free of charge but place is limited.


GMP Training Course at Biopark Regensburg, 19th of July 2017

Dr. Hans-Georg Eckert, GMP senior consultant at Valicare GmbH, executed a GMP training course at the lecture hall of Biopark in cooperation with the Biopark Regensburg. The numerous participants coming from university and university hospital demonstrates that GMP is a subject in the academic fields, too. Beyond that representatives of biotech companies of the Biopark and the BioRegio Regensburg followed the invitation to fresh up their GMP knowledge and to get answers on special questions. All participants finished the training successfully and took a GMP training certificate home. An ongoing cooperation with the Biopark Regensburg is scheduled.


GMP-Compliance audit, 5th to 6th of July 2017

The ATMP GMP audit team of the Valicare GmbH executed a GMP compliance audit from 5-6th of July at a potential contractual partner of an internationally working pharmaceutical company. The manufacturing of an advanced therapy medicinal product (ATMP) was proved on GMP compliance to formulate the frame conditions for the quality agreement and the requirements for the product. Initial application of the ATMP is planned under hospital exemption regarding §4b of the german drug law and shall be followed by a central european marketing authorization in the near future.


Forum Science & Health, Fürstenfeldbruck, 5th to 6th of July 2017

Forum Science & Health, an event of the “Cluster Biotechnology Bavaria”, takes place at Fürstenfeldbruck near Munich. Personalized medicine of the future is the focus of the meeting. An interdisciplinary viewing and discussions with the aim of developing a medicine bypassing all the different medical fields.

Meet Valicare GmbH at our booth at “Altes Foyer” and find out which GMP services we can provide you in this specific field of technology.


APV Focus Group Meeting at Robert Bosch GmbH, 19th to 20th of June 2017

APV Focus Group Pharmaceutical Biotechnology will come together at the Robert Bosch Packaging Technology GmbH side in Crailsheim, following an invitation of Dr. Hans-Georg Eckert, senior project manager & GMP-consultant at Valicare GmbH, Frankfurt.

The APV Focus Group representing the area of pharmaceutical biotechnology is engaged with the production and application of drugs or medical devices under application of whole organisms or parts of them. On the regular occurring meetings scientific and methodical information are exchanged. This time lectures like “Newest status of GMP for ATMP“ und “Manufacturing of investigational drug products and starting material for cell and gene therapy” are planned before a sightseeing at the Bosch Packaging Technology site in Crailsheim, competence center for construction and manufacturing of aseptic filling lines, will start.


Further information

Dr Claudia Papewalis is giving a GMP for ATMP training


If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".