Business talk between several persons

DG-GT Theme Day, Leipzig, 16-17th of September, 2019:

This year’s Annual Meeting of the German Society for Gene Therapy e.V, (DG-GT e.V.) will take place in Leipzig in collaboration with the Fraunhofer Institute for Cell Therapy and Immunology (IZI Fraunhofer).

From 16th of September to 17th of September 2019 the experts of gene therapy will participate in the Theme Day “CAR-T cells and beyond” at the Fraunhofer Institute in Leipzig.

During six sessions, the whole spectrum of CAR-T cell development will be discussed, starting with pre-clinic and vector production, following with regulation and ethical question, and ending with clinical studies. On the evening of 16th of September there will be a networking social reception with a subsequent tour through the city of Leipzig.

The DG-GT found in 1994 by natural scientists and physicians and since then focuses on the different aspects of gene therapy and its clinical application. Of particular concern are the support of young researchers by offering mentorship and a Summer School, as well as the communication of scientific research to the public. Another important object of DG-GT is the Europe-wide standardization of a gene therapy set of rules. Last but not least, the DG-GT offers a platform for the exchange of information and discussion. An Annual Meeting thereby offers a networking of related professional societies on a national and international level.

Our GMP- and ATMP-experts from Valicare, Dr. Claudia Papewalis and Dr. Mario Ramos Tirado, both specialists for GMP for Advanced Therapy Medicinal Products (ATMPs) will take part at the DG-GT 2019 Theme Day. You will find them in the expert audience of the sessions, but also at the accompanying exhibition with an information booth. They are looking forward to talk with you about our service support to get ATMPs from bench to market. A special surprise awaits all visitors at our Valicare booth.


GMP compliance training for ATMPs in Würzburg, 10th of July, 2019:

Dr. Claudia Papewalis and Dr. Hans-Georg Eckert, Senior GMP Consultants at Valicare GmbH, will conduct a half-day training course on GMP compliance for ATMPs and combination products at the University Hospital in Würzburg on 10th of July, 2019.

Marius Gensler, PhD student of the department "Tissue Engineering and Regenerative Medicine", who had the luck to win one of the half-day GMP trainings at the Biotechnology Days in Würzburg from 09th to 10th of April at the booth of Valicare GmbH, organized the corresponding premises and published the invitation & agenda on the campus.

GMP for ATMPs is a very interesting and important topic for students, PhD students and lecturers, as shown by the high number of 50 registrations. We are looking forward to meet the participants at the training and hope on manifold questions and inspiring discussions during or at the end of the event.

The successful participation will be confirmed by a certificate after the training.


Annual Meeting of CIMT, Mainz, 21-23th of May, 2019:

The Association for Cancer Immunotherapy CIMT is holding their 17th annual Meeting from 21st to 23rd of May 2019 in the Rheingoldhalle Congress Center Mainz, Germany. CIMT is an independent non-profit organization, fostering knowledge exchange and collaboration within the global cancer immunotherapy community. Members of CIMT range from researchers to physicians to regulatory authorities, forming the information and education platform for high-level science on cancer immunotherapies. This year’s CIMT 2019 focuses on the topics of neoantigens, cellular therapy, improving immunity, tumor microenvironment, regulatory research and immunoguiding, both for pre-clinical research and for clinical development. The plenary sessions are complemented amongst others by an industry exhibit. Here, at booth no. 4, our GMP experts Dr. Hans-Georg Eckert and Dr. Claudia Papewalis (Senior GMP Consultants) will answer on your questions regarding GMP compliance and especially for ATMPs. Visit our booth and with a little luck you will win an half-day GMP training course provided you solve the riddle.


Pharmatag of Bosch Packaging Technology, Crailsheim and Künzelsau, 21-22th of May, 2019:

Crailsheim, Germany – Bosch Packaging Technology Crailsheim invites international pharmaceutical guests to its Pharmatag 2019 from May 21 to 22 under the motto "Expertise for the perfect flow". Visitors to the traditional event will experience two days of exciting lectures, an exclusive plant tour and live demonstrations.

The second day traditionally includes the symposium with lectures from the pharmaceutical industry, which takes place at the Carmen Würth Forum in Künzelsau. Here you have the opportunity to inform yourself about the latest innovations in the field of process technology on a 200 sqm exhibition area.

Valicare GmbH will also be represented in Künzelsau on May the 22th to answer on your questions about GMP and ISO compliance services. We look forward to talking to you at our stand.

Especially topics regarding GMP-compliant risk-based qualification and validation, gap analysis, audits and inspections or supllier qualification can be discussed with our certified auditor, Mr. Mohsen Masoumi. We look forward to welcome you.


German Biotech Days, Würzburg, 9-10th of April, 2019:

The German Biotech Days (DBT), held annually as a two-day event, will take place on 09th and 10th of April 2019 in Würzburg. The conference is co-organized by BIO Deutschland and the Council of German BioRegions, as well as BioM as the host and the local partners IGZ Würzburg and BioPark Regensburg. The German Biotech Days became the leading networking platform for the German biotech industry where all stakeholders in Germany’s biotech scene exchange their views and experiences. For more than 850 representatives from the world of business, science and government, including partners from funding institutions and public administration the forum is a meeting place, offering a versatile program of talks, panel discussions and breakfast sessions. Besides the common topics “medicinal biotechnology”, “industrial biotechnology” and “research”, the topic “technology transfer” will be picked-up again.

Valicare experts will participate at the congress but also at the industrial exhibition. Visit our GMP-experts of Valicare GmbH at booth 7 of the accompanying exhibition for companies, research institutes, association and organization. We will answer your questions concerning ISO and GMP compliance of your pharmaceutical or biotechnological manufacturing process, but also especially concerning advanced therapy medicinal products.


Gene Therapy Conference, Frankfurt am Main, 30-31th of January 2019:

The conference "Gene Therapy-Ready for the Market" organized by the working group "Cell Culture Technology and Medicinal Biotechnology" of Dechema will take place from 30-31th of January at the Dechema in Frankfurt. In addition to numerous extremly interesting lectures on the subject of gene therapy, service providers will be organizing a trade exhibition. You are welcome to inform yourself at the Valicare booth about our extensive GMP service portfolio in general and especially in the field of advanced therapy medicinal products (ATMPs) drugs for novel therapies.


GMP for ATMP training, 9.05.2019 and 5.09.2019:

This training course especially addresses to GMP specifications for ATMPs. Particularly, you will be introduced to the characteristics and regulatory peculiarities of ATMPs and will get an overview of the basic requirements of the special GMP guidelines for ATMPs. Your seminar leader Ms. Dr. Papewalis works as a Senior GMP Consultant and Project Manager at Valicare GmbH with many years of experience in clinical development and manufacturing of ATMPs. Therefore, she is well versed in regulatory requirements for ATMPs. Take the opportunity to update your knowledge and to ask questions of your practical experience. The training takes place at Valicare GmbH in Frankfurt am Main.

Although the 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 training about risk based qualification, 26.03.2019 and 22.10.2019:

The main subject of this GMP training course comprises the risk-based GMP-compliant qualification of equipment and systems. Here you will get an instruction of the basics of "Good Manufacturing Practice" and international regulation requirements and further an introduction of proceedings the risk-based qualification approaches in the context of a validation project. Your trainer Mr. Mohsen Masoumi is an experienced Senior GMP Consultant and Project Manager at Valicare GmbH who successfully carried out numerous qualification and validation projects in the pharmaceutical industry. As an expert in this domain, he is well experienced in theory and practice and ready to answer on your special questions after the training. The training takes place at Valicare GmbH in Frankfurt am Main.

Although the 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 training about validation of analytical methods (AMV), 12.09.2019:

Within this GMP training course, the validation of analytical methods (AMV) which is used for the production, development and release of drugs (especially ATMPs) will be intensively discussed. Learn more about the regulatory requirements (ICH Q2(R1)) for the validation of suitable test methods for routine use, validation characteristics, suitable acceptance criteria, statistical significance tests and validation documentation. Your seminar leader Ms. Dr. Katherina Pfister works as GMP Consultant at Valicare GmbH with deep experience in theory and practice of AMV. After the session, she will be ready to answer your special questions on this field. The training takes place at Valicare GmbH in Frankfurt am Main.

Although the 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.


The Forum Translational Medicine will take place in Würzburg from 28-29.11.2018:

From 28 to 29 November, the BioM organizes on behalf of the Bavarian State Ministry of Economics, Energy and Technology the "Forum Translational Medicine" in Würzburg. The main topic of this event is the translation of new active substances, therapy methods or diagnostics into the market and for the benefit of patients. Therefore, experts will report on current successful translations in the (bio-) medical field and comment on the general hurdles and manifold regulatory requirements. Moreover, this event focuses on immunotherapy and the current approaches around CAR-T therapies and CRISPR/Cas9. Sessions discussing diagnostics and therapy for infectious diseases, cardiovascular diseases and diabetes will also be part of an interesting program.

Visit GMP Consultants of the Valicare GmbH in the accompanying industrial exhibition. They will answer any questions you may have about ISO or GMP compliance of your pharmaceutical or biotechnological manufacturing process, or specifically in the field of advanced therapy medicinal products (ATMP).


PharmaLab 2018, 20-21 .11. 2018 in Düsseldorf/Neuss:

The PharmaLab 2018 is Congress & Exhibition for Analytics, Bioanalytics and Microbiology and offers an excellent opportunity to obtain comprehensive information on current developments in the field of analytical laboratory methods and regulatory requirements. In this connection, experts will report and advise on the qualification of equipment and systems, the validation of analytical methods and microbiological tests and their improvement for routine use. Take the opportunity to update your knowledge and discuss your open questions with colleagues, speakers and exhibitors.

Visit us at booth 18 if you have questions regarding the validation of analytical methods according to ICH Q2(R1) or especially in the field of alternative therapies. We are looking forward to see you. A little surprise is waiting for you too.


Interactive workshop focused on Advanced Therapy Medical Products (ATMP), 27-28.09.2018:

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.

Three round table discussions each headed by two or three experts will provide a platform for the participants to discuss their own topics, issues, and strategy in an interactive manner.


GMP Training Course at Biopark Regensburg, 19.07.2017:

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, 5-6.07.2017:

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.


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".