GMP for Advanced Therapy
Medicinal Products Regulatory, industrial and scientific view of the current guidance documents Current Regulatory Developments
SPEAKERS:
Jacqueline Barry Cell and Gene Therapy Catapult
Dr Georg Belke-Louis Apceth Biopharma GmbH, Germany
Dr Andrea Hauser José Carreras Center for Somatic Cell Therapy Dr Ralf Sanzenbacher Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines Join us at the pre-Workshop Dr Jürgen Scherer Get-Together on 27 March Paul-Ehrlich-Institut, in the NH Hotel German Federal Agency for Vaccines and Biomedicines 28 March 2017, Frankfurt/Mörfelden, Germany
Dr Gabriele Wanninger GMP Inspectorate PROGRAMME: of the Local Govern- ment Upper Bavaria Regulatory and Non Regulatory View on the Current Guidelines Inspection Experiences Practical Experiences with the Implementation of GMP in Clinical Trials GMP Aspects for Manufacturing of Cells and Cell-based Products
This education course is recognised for the ECA GMP Certification Programme „Certified Biotech Manager“. Please find details at www.gmp-certification.eu GMP for Advanced Therapy Medicinal Products 28 March 2017, Frankfurt/Mörfelden, Germany
Objectives Programme
Considering the ongoing development of the new GMP GMP for ATMP – A Regulatory View related guideline documents for Advanced Therapy Me- Development of the current Guidance Documents dicinal Products, this workshop aims to provide an insight GMP Aspects and Trends view in the discussion and the proposed regulatory Regulatory Considerations adaptions on ATMP with a focus on GMP aspects impor- Jürgen Scherer, Paul-Ehrlich-Institut tant for development and manufacturing of Advanced Therapy Medicinal Products. Representatives from au- GMP for ATMP - Practical Considerations for thorities, consulting as well as from academia and manu- Developers facturers will share their experiences with you and give Comparison of new Guidance with Volume 4 you the possibility to discuss intensively the challenges Considerations for Developers for ATMPs. Next Steps and Recommendations Jacqueline Barry, Cell and Gene Therapy Catapult
Background Case Study – Manufacture of an ATMP for a Phase I/II Clinical Trial in an Academic Setting Advanced therapy medicinal products (ATMP) represent Installation of a Clean room Facility for Manufacture of an emerging class of innovative biopharmaceutical med- ATMPs in an Academic Setting icines, summarizing gene therapy, somatic cell therapy Establishment and Validation of the Manufacturing and tissue-engineered products. With adoption of the process with Special Focus on GMP Compliant FACS ATMP regulation EC 1394/2007, all ATMPs are regarded Sorting as medicinal products and must consequently comply Application for a Phase I/II Investigator Initiated with current EU drug legislation including GMP require- Clinical Trial ments. Pharma industry recently increased their activities Dr. Andrea Hauser, José Carreras Center for Somatic Cell to this new area, nevertheless the development of these Therapy complex products is still focused at universities, hospitals and spin off companies derived thereof (small medium Specific Quality Issues of Cell-based Products and enterprises, SME). This implicates special challenges for Inspection Experiences compliance of the different stakeholders with regulatory Process development requirements on GMP. Quality of Reagents and Materials Important Aspects for Characterisation and Control of Cells Target Audience Relevant Guidance Documents Inspection Experiences and Findings This course is advisable to people who Common Quality Deficiencies in Clinical Trial Applications are involved in basic or translational research on cell- Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut or gene-based therapy concepts with the perspective of clinical application, GMP Implementation for advanced cell and cell based are responsible for quality aspects on ATMP, products at a CDMO implement GMP in ATMP manufacturing, Pecularities of ATMPs are involved in regulatory inspections of ATMP, Challenges of Manufacturing and QC throughout the are responsible for GMP requirements during pre- different clinical stages approval phases. GMP Implementation in a CDMO company with mul- tiple customers Ulrike Verzetnitsch, Apceth Biopharma GmbH Moderator GMP Inspection Experiences Dr Ralf Sanzenbacher, PEI and GMP for Clinical Phases Axel H. Schroeder, Concept Heidelberg Inspection Expectations and Experiences Dr Gabriele Wanninger, Local Government Upper Bavaria Speakers Since 2006 he has been involved in the scientific evalua- tion of tissue preparations and cell-/tissue-based medici- Jacqueline Barry, Catapult, UK nal products within national and European regulatory Jacqueline Barry is Director of Regulatory Af- procedures, with a strong focus on quality. He is also en- fairs for Cell and Gene Therapy Catapult, the gaged in the development of regulatory guidance for UK’s centre for the acceleration of the transla- these products. In addition, he is member or adviser to tion of cell therapies towards commercialisa- several cell therapy expert panels. tion. Prior to this Jacqueline worked at the Scottish Na- tional Blood Transfusion Service in a number of senior Dr Jürgen Scherer, Paul-Ehrlich-Institut, regulatory and quality positions, the responsibility for German Federal Institute for Vaccines and which included designing the regulatory strategy for the Biomedicines Cellular Therapies developed by the Blood Transfusion Jürgen Scherer studied Biology at the Service, acting as Responsible Person for Blood and Johannes-Gutenberg-University Mainz (Ger- Qualified Person for medicinal product release. Before many). After his PhD graduation at the Max-Planck-Insti- that she held a number of post-Doctoral academic posts tut for Brain Research (Germany) and a postdoctoral fel- lowship at the Max-Delbrück Centre, he joined 1993 the at the University of Edinburgh studying neuromuscular Paul-Ehrlich-Institut. His current position is Head of Sec- regeneration. She has considerable experience in the de- tion of the unit Advanced Therapy Medicinal Products, velopment, translation, clinical trial and approval of cell Tissue Preparations. based medicinal products and therapies. Dr Gabriele Wanninger, Head of the Depart- Dr. med. vet. Georg Belke-Louis, Head of ment Pharmacy, Inspectorate Southern Ba- GMP Manufacturing and Process, apceth varia, Government of Upper Bavaria, Biopharma GmbH, Ottobrunn München, Germany Georg Belke-Louis studied Veterinary Medi- Gabriele Wanninger studied Pharmacy at the cine in Munich. After his degree, he worked at University Munich and received her PhD in 1985 in phar- the institute for Pharmacology, Toxicology and Pharma- maceutical chemistry. Until 1995 she was analyst at the ceutics. After that he worked in different positions for Bavarian OMCL. From 1995 – 2002 Gabriele Wanninger Munich Biotech, and MediGene. 2011 he joined apceth was GMP Inspector and deputy head of the Department as Head of Manufacturing and Process of ATMP Pharmacy, Government of Upper Bavaria and after that Head of the Department Pharmacy and authorised per- Dr Andrea Hauser, Jose-Carreras-Centrum, son for quality assurance of Bavarian inspectorates, Ba- University Hospital Regensburg varian Health and Food Safety. Since September 2013 she Andrea Hauser is Head of Operations, Head is Head of the Department Pharmacy, inspectorate of Production and Head of Quality Assurance Southern Bavaria, Government of Upper Bavaria. at the José-Carreras-Centre for Somatic Cell Therapy, a department of the University Hospital Regens- burg. She studied Pharmacy at the University of Regens- Get-together on 27 March 2017 burg. After that she was working as a GMP inspector at the Government of Upper Bavaria in Munich, where she On 27 March 2017, the even- conducted numerous GMP and GCP inspections mainly ing before the Workshop, you in the field of blood, tissue and (stem) cell therapy. Dr are cordially invited to a so- Hauser holds the qualification to act as Qualified Person. cial event at the nh Hotel. This is an excellent opportu- Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut, nity to share your experiences German Federal Institute for Vaccines and with colleagues from other Biomedicines companies in a relaxed at- Ralf Sanzenbacher, PhD, graduated in biology mosphere. Starting time is 18.30 h. with a focus on immunology at the Technical University of Darmstadt, Germany. Following a postdoc- toral research fellowship at the Institute of Immunology of the University Clinics Schleswig-Holstein, Kiel, he joined the Paul-Ehrlich-Institut (PEI), where he continued his scientific studies on cellular signaling and virus-host cell interactions. Currently, Ralf Sanzenbacher serves as Deputy Head of the Section “Tissue Engineering and So- matic Cell Therapy Medicinal Products” at the PEI. Easy Registration Reservation Form: Reservation Form: e-mail: Internet: CONCEPT HEIDELBERG + 49 6221 84 44 34 @ [email protected] www.gmp-compliance.org P.O. Box 10 17 64 69007 Heidelberg Germany
Date
Get Together 27 March 2017, 19.00 - 22.00 h
Workshop GMP for ATMP Tuesday, 28 March 2017, 09.30 – 17.30 h (Registration and coffee 09.00 - 09.30 Uhr) + 49 6221 84 44 34 Venue NH Frankfurt Mörfelden Hessenring 9 Country 64546 Mörfelden-Walldorf Phone +49(0)6105-204 0 Email [email protected] note that I can ask for the modification, correction or deletion of note that I can ask for the modification, correction my By registering for this event, I accept the processing the processing for this event, I accept By registering Policy: Privacy will use my data for the Heidelberg Data. Concept of my Personal that my to agree declare for which I hereby ofprocessing this order, will only Heidelberg Concept and processed. personal data is stored or similar ones. My with this order send me information in relation (see also the pri - parties personal data will not be disclosed to third vacy policy at http://www.gmp-compliance.org/eca_privacy.html). I data at any time via the contact form on this website. Fees (per delegate plus VAT)
Non-ECA Members € 890
(please fill in) (please ECA Members € 790 APIC Members € 845
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Accommodation
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Registration
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Conference language
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Organisation and Contact
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