23rd APIC/CEFIC Global GMP & Regulatory API Conference 2020 - GMP Part

23rd APIC/CEFIC Global GMP & Regulatory API Conference 2020 - GMP Part

Amsterdam, Netherlands

Course No 17694

 

Costs

ECA-Member: EUR 1596,--
Regular Fee: EUR 1680,--
EU/GMP Inspectorates: EUR 1260,--
APIC Member Discount: EUR 1512,--

(All prices excl. VAT)

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

Speakers

Hélène Bruguera, EDQM France
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Katherine Eban
Stephan Heck, Catalent Pharma Solutions, Germany
Dr Sau (Larry) Lee, US FDA, USA
George Hartong van Lokven, Aspen Oss B.V., The Netherlands
Nuno Matos, Hovione, USA
Beate Miller, DSM Nutritional Products, Switzerland
Frank Montgomery, AstraZeneca
Ibrahim H. Mujammami, SFDA, Saudi Arabia (invited)
Jeong-Ja Oh, Synex Consulting, South Korea
Cathal O’Duinn, Janssen Pharmaceuticals, Ireland
Rosimeire Pereira Alves da Cruz, ANVISA, Brazil
Fabio Polato, Sandoz, Austria
Florent Trouillet, Siegfried, Switzerland
Dieter Vanderlinden, Ajinomoto Bio-Pharma Services, Belgium
Stefaan van de Velde, Ajinomoto Bio-Pharma Services, Belgium

Objectives

The APIC/CEFIC Global GMP & Regulatory API Conference is Europe’s leading API event. Many major stakeholders from Authorities and the Industry are joining this Conference each year. Speakers from EMA, EDQM, FDA, National Authorities, the Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.
 
The GMP part of the Conference, of which the final module is a Joint GMP & RA session, provides updates from recent authorities’ initiatives, activities and interpretations related to GMP compliance of API manufacturing. Hear from industry speakers about their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP.
 
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.

Programme

GMP part
 
Development and application of Mutual Recognition Agreements
Speaker to be named by EMA
 
Proactive application of operational excellence in the external supply chain
Cathal O’Duinn, Janssen Pharmaceuticals
  • Framework for deployong operational excellence
  • Data driven approach to risk identification
  • Proactived deployment and sustainability
Life Cycle approach to process validation
Stefaan van de Velde, Ajinomoto Bio-Pharma Services
  • How science and risk based logic can help continuously improving processes
  • Practical approach
ANVISA’s view on inspections
Rosimeire Pereira Alves da Cruz, ANVISA
  • Status and Review of current inspection activities
  • Top 10 Findings from ANVISA’s inspections
  • Outlook on future inspection program
Risk based approach to supplier management
Dieter Vanderlinden, Ajinomoto Bio-Pharma Services
  • Regulatory requirements  and expectations
  • Industry best practices - how to manage suppliers?
  • Elements to consider to support risk based approach
Fraud in generic pharmaceutical manufacture: A worldwide life-threatening danger
Katherine Eban
  • The various forms of fraud
  • How inspectors are being fooled
  • How do APIs fit in?
  • Are we solving the problems?
 
Parallel Sessions
 
Quality culture
Stephan Heck, Catalent Pharma Solutions
  • What is quality culture?
  • Why is the quality culture of an organisation important to APIs and patients?
  • How is the quality culture of an organisation developed?
  • How can you assess an organisation quality culture?
Specifics for Sterile APIs
Fabio Polato, Sandoz
  • Sterile API production – Annex 1 GMP
  • Regulatory consequences
  • The relationship with the customers
ICH Q13 – Continuous Manufacturing of Drug Substances and Drug Products
Nuno Matos, Hovione
  • ICH Q13 purpose
  • Continuous Manufacturing process benefits for Industry
  • Guideline status and next steps
API registration in Brazil: an overview
George Hartong van Lokven, Aspen Oss B.V.
  • Brazil specifics
  • Registration procedures: past, present and future
Cleaning in multipurpose facilities
Florent Trouillet, Siegfried (Evionnaz)
  • Health authorities’ requirements and cleaning challenges for multipurpose facilities
  • Criteria for risk analyses to develop cleaning methods and cleaning validation strategy in a multipurpose facility
  • Risk-based approach for limit setting on intermediates and early development products
  • Practical examples
APIC´s Experience with API Registrations in China
Beate Miller, DSM Nutritional Products
  • The Regulatory Framework in China
  • Chinese DMF Requirements
  • Experience of APIC Members & Case Studies
 
Joint GMP And Regulatory Affairs part
 
Update from EDQM
Hélène Bruguera, EDQM
  • Latest news on the certification scheme
  • The EDQM inspection programme
Latest developments in nitrosamine impurities – impact to the API industry
Speaker to be announced, Member of the APIC Task Force on Nitrosamines
  • Why are nitrosamines a concern?
  • What is expected from the API Industry from a GMP and regulatory perspective?
  • Interactions between API Industry and marketing authorisation holders
ICH Q12 - Now the hard work starts in implementation
Frank Montgomery, AstraZeneca
  • How to define ECs and where in the CMC should they be listed
  • PACMP – advantages and how to use
  • PLCMP – advantages and how to use
Innovation and continuous manufacturing
Dr Sau (Larry) Lee, FDA
  • FDA’s efforts to modernize drug manufacturing
  • Guidance for Industry: Quality Considerations for Continuous Manufacturing
  • Batch vs. continuous manufacturing
  • FDA’s Emerging Technology Program

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