GMP for Advanced Therapy Medicinal Products (ATMP)

GMP for Advanced Therapy Medicinal Products (ATMP)

Frankfurt/Mörfelden, Germany

Course No 15769


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Jacqueline Barry, Cell and Gene Therapy Catapult

Dr. med. vet. Georg Belke-Louis, Head of GMP Manufacturing and Process, apceth
Biopharma GmbH, Ottobrunn

Dr Andrea Hauser, José Carreras Center for Somatic Cell Therapy

Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines

Dr Jürgen Scherer, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines

Dr Gabriele Wanninger, GMP Inspectorate of the Local Government Upper Bavaria

Objectives

Considering the ongoing development of the new GMP related guideline documents for Advanced Therapy Medicinal Products, this workshop aims to provide an insight view in the discussion and the proposed regulatory adaptions on ATMP with a focus on GMP aspects important for development and manufacturing of Advanced Therapy Medicinal Products. Representatives from authorities, consulting as well as from academia and manufacturers will share their experiences with you and give you the possibility to discuss intensively the challenges for ATMPs.

Background

Advanced therapy medicinal products (ATMP) represent an emerging class of innovative biopharmaceutical medicines, summarizing gene therapy, somatic cell therapy and tissue-engineered products. With adoption of the ATMP regulation EC 1394/2007, all ATMPs are regarded as medicinal products and must consequently comply with current EU drug legislation including GMP requirements. Pharma industry recently increased their activities to this new area, nevertheless the development of these complex products is still focused at universities, hospitals and spin off companies derived thereof (small medium enterprises, SME). This implicates special challenges for compliance of the different stakeholders with regulatory requirements on GMP.

Target Group

This course is advisable to people who

  • are involved in basic or translational research on cell- or gene-based therapy concepts with the perspective of clinical application,
  • are responsible for quality aspects on ATMP,
  • implement GMP in ATMP manufacturing,
  • are involved in regulatory inspections of ATMP,
  • are responsible for GMP requirements during pre-approval phases.

Get-together on 27 March 2017

On 27 March 2017, the evening before the Workshop, you are cordially invited to a social event at the nh Hotel. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere. Starting Time 18.30 h

Programme

GMP for ATMP – A Regulatory View

  • Development of the current Guidance Documents
  • GMP Aspects and Trends
  • Regulatory Considerations
GMP for ATMP - Practical Considerations for Developers
  • Comparison of new Guidance with Volume 4
  • Considerations for Developers
  • Next Steps and Recommendations
Case Study – Manufacture of an ATMP for a Phase I/II Clinical Trial in an Academic Setting
  • Installation of a Clean room Facility for Manufacture of ATMPs in an Academic Setting
  • Establishment and Validation of the Manufacturing process with Special Focus on GMP Compliant FACS Sorting
  • Application for a Phase I/II Investigator Initiated Clinical Trial

Specific Quality Issues of Cell-based Products and Inspection Experiences
  • Process development
  • Quality of Reagents and Materials
  • Important Aspects for Characterisation and Control of Cells
  • Relevant Guidance Documents
  • Inspection Experiences and Findings
  • Common Quality Deficiencies in Clinical Trial
  • Applications
GMP Implementation for advanced cell and cell based products at a CDMO
  • Pecularities of ATMPs
  • Challenges of Manufacturing and QC throughout the different clinical stages
  • GMP Implementation in a CDMO company with multiple customers
GMP Inspection Experiences
  • GMP for Clinical Phases
  • Inspection Expectations and Experiences


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