Dr. Stephan Kiessig
PreviPharma Consulting
Referent:innen
Dr. iur. Bita Bakhschai
Rechtsanwälte Scheller & Kollegen
Michael Schiffer
CSL Behring
Dr. Manuel Hafner
Loba Biotech
Zielsetzung
During this conference, speakers from authorities, industry, sciences and donation services provide you with information about the current developments and revisions of the regulatory requirements, e.g. for mass spectrometry, Annex 1 and blood labeling. Furthermore, important topics such as inspections from the perspective of a GMP inspector, stability study management and virus safety will be considered. You will benefit from experts presenting their practical experiences and knowledge in the field of quality and safety of blood, blood products and plasma.
Other information provided during this event includes developments in plasma protein research, automation in a process lab, asset management and much more.
Other information provided during this event includes developments in plasma protein research, automation in a process lab, asset management and much more.
Hintergrund
In July 2022, the European Commission adopted the proposal for a Regulation on standards of quality and safety of substances of human origin intended for human application. The Council agreed on its negotiating mandate in October 2023. Negotiations with the European Parliament began in November 2023 and conclude with provisional agreement since Dec 2023. With the repeal of the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC), the Regulation finalizes the revision of the regulatory framework for blood, tissues and cells in the light of new scientific, technical and societal developments. It aims to prioritize and ensure donor safety, patient safety, security of supply and the development of innovative medical procedures in Europe.
Furthermore, the EU GMP Guideline, Annex 1 „Manufacture of sterile medicinal products“ also came into effect on 25 August 2023.
But what impact will these two new regulations have on donation centres and on companies that manufacture blood and plasma products in Europe? A harmonized regulation is essential for patient safety as well as the quality of the products, but new regulations often raise many questions and should definitely be clarified before inspection by the authorities.
Furthermore, the EU GMP Guideline, Annex 1 „Manufacture of sterile medicinal products“ also came into effect on 25 August 2023.
But what impact will these two new regulations have on donation centres and on companies that manufacture blood and plasma products in Europe? A harmonized regulation is essential for patient safety as well as the quality of the products, but new regulations often raise many questions and should definitely be clarified before inspection by the authorities.
Take the opportunity to exchange experiences with experts at this event and also talk about new developments, e.g. in analytics, production, products and existing issues and problems, e.g. inspections, blood labeling and more.
Zielgruppe
This conference is designed for persons from
- Donation services/Blood Services
- QA Staff
- National and international Authorities
- Plasma Fractionation
- Control Laboratories
who are involved in regulatory affairs, quality assurance, quality control and manufacturing of blood, blood products or Plasma.
Presentations / Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
How the Verdict of the CJEU relating to MSM has been implemented in German Law
- Consequences of the Judgment of the CJEU (Court of Justice of the European Union) of 29 April 2015 (C-528/13)
- Does the fact that a man has had or has sexual relations with another man (MSM - men having sex with men) constitute “sexual behaviour”?
- German Transfusion Act (“Transfusionsgesetz”) in the version of May 2023
- German “Guideline Hemotherapy” of the Federal Chamber of Physicians
Short Overview of the “Proposal for a Regulation on Substances of Human Origin”
This new proposal, inter alia,
- supports the continued provision of SoHO therapies,
- ensures high safety and quality standards,
- improves harmonisation across member states, facilitating cross-border exchange of SoHO and improving patient access to the therapies they need,
- creates conditions for safe, effective and accessible innovation,
- improves crisis preparedness and resilience to safeguard access to therapies.
Current regulatory Challenges in the Field of Blood and Plasma Products
- Evaluation of epidemiological data on blood transmissible infections:
- current guideline and current practical approaches
- future perspectives and next steps - SoHO: impact of the novel regulation and next steps
Trends in Innovation and Development in PDMPs
- Current status of plasma sourcing outside EU and USD
- Plasma testing
- Current trends in the product development and indications
- Fractionation market
- Current fractionation
- Trends outside EU / US
- New equipment
A Glimpse into the Future of Biopharmaceutical Manufacturing
- Trends in biopharma / Industry 4.0
- Some examples of PAT
- Sustainability
Recent Developments in Plasma Protein Research at CSL
- CSL: a plasma-based biotech
- Nebulised IgG in respiratory disease
- Heme- and Hemoglobin scavengers
Possibilities for Automation in a Process Lab
- Overview Takeda Process Labs
- Digitalisation & Automation
- KPIs as a tool for decision-making
- Challenges & opportunities
Inspections of Blood Establishments by Authorities
- Current legal Framework
- Inspection procedure
- Challenges and outlook
Why is a unique Identification of Substances from Human Origin important?
- Unique, ISO conform coding of blood, tissue, cells and other substances of human origin
- Eurocode IBLS is a non-profit organisation managed by medical professionals in the field
- Eurocode coding system is compatible with EU tissue coding system and ISBT 128 managed by ICCBBA in the field of tissues and cells
Asset Management in the Pharmaceutical Industry
- What is asset management, and why might you need it?
- Available technologies and hurdles in relation to frozen materials (Plasma/Intermediates)
- why QR/Barcodes are bad - Sample Use Cases
Annex 1 Contamination Control Strategy
- New GMP Annex 1 requires contamination control strategy
- Contamination control strategy shall be holistic approach covering facility, raw materials and process
- Stability Study Management – unifying the World under different Conditions - Dr Sophie Fröhlich
- A product is a product is a product: stability-related challenges and requirements from East to West
- Cost-benefit ration und regulatory requirements – limitations for increasing study effectiveness by predictive analysis
- Reducing tests increasing data analysis capabilities - time efficiency in the bottleneck for submissions
Mass Spectrometry and its Opportunities in Drug Development: an old Hat or the Future?
- LC-MS/MS in stability testing of drugs
- LC-MS/MS and the detection of impurities in pharmaceutical products
- LC-MS/MS and its opportunities to investigate isoforms of blood proteins (immunoglobulins, coagulation factors, plasminogen)
- C-MS/MS for the optimization of production conditions
Defending against the Unseen: Mastering Virus and TSE Safety through holistic Safety Concepts and Contamination Control Strategies
- Design of a state-of-the-art plasma product pathogen safety profile
- CCS: Consideration of the new EU GMP Annex I for the pathogen safety of PDMPs
- Intra- and inter-batch segregation concepts
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This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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E-Mail: info@concept-heidelberg.de
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