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
- The various forms of fraud
- How inspectors are being fooled
- How do APIs fit in?
- Are we solving the problems?
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