27th APIC/CEFIC Global GMP & Regulatory API Conference
Wednesday | 23 October
The first day of the Conference provides, besides the first set of Parallel Sessions with various GMP and RA topics, updates about EDQM’s activities, the EU Critical Medicines Act and the latest status of PFAS (per- and polyfluoroalkyl substances).
Update from the EMA Quality Working Party
Monika Mayr, EMA
- Recent reorganisation of the QWP (and reasons behind it)
- Current priorities and the workplan of the QWP
- Ongoing guidance work, including on control of nitrosamines and the revision of the guideline on chemistry of active substances
PFAS - From hero to zero
Erik Kateman, Aspen Oss
- Introduction
- Properties
- Uses
- Restriction proposal
- Challenges
CEP 2.0 - Perspective of MA Holder
Karina Boszko, Polpharma API
- Pros and Cons for FDF manufacturer
- Challenges in using CEP 2.0
- Cooperation with EDQM regarding CEP 2.0
The critical medicines act: an enabler for the open strategic autonomy of the EU pharmaceutical supply chain?
Maggie Saykali, Cefic
- Role of API producers in ensuring the resilience and security of supply of the European pharmaceutical supply chain and in responding to fluctuations in demand.
- Innovation as a key competitiveness enabler for EU manufacturers
- Current EU landscape: initiatives to support the pharmaceutical supply chain at EU and national level
- The EU Critical Medicines Act: the ultimate answer to Industry’s needs?
Update from the EDQM
Hélène Bruguera, EDQM
- 60 years of contribution to public health protection
- Updates and roadmap of the Ph. Eur.
- Updates and roadmap for the CEP procedure
- How does EDQM support initiatives to handle shortages
Thursday | 24 October
The API world is changing rapidly. On the second day, the focus will be on the second set of Parallel Sessions about e.g. ICH M4Q(R2), Recycled raw materials in API manufacturing, API Registration in China, Process-Equipment-Related Leachables (PERLs) and the new guidance document of APIC about aspects of cleaning validation in API plants.
Development and regulatory challenges for Peptides
Srikanth Thallapally, Sandoz
Andreja Vuckic, Lek Pharmaceuticals
- Differences in regulatory requirements between US and Europe
- Need for setting guidelines for Impurities thresholds in ICH
- Life cycle management process and challenges
- Importance of DMF (API supplier) role in drug product approval
A sustainable API company: the long and winding road
Joris Gilberts, Aspen Oss
- Reduce resource usage in existing production processes
- Sustainable API synthetic routes
- Circularity in API production: reality or science-fiction?
- Sustainability is more: Social and Governance topics
Data Integrity Assurance: Have You Implemented Sustainable Practices and Controls?
Ruth Moore, US FDA
- ALCOA+ requirements and effective Data Governance.
- Risk Assessment for Data Criticality and Gap Analysis to Identify Vulnerabilities.
- Case Studies from recent Warning Letters to API Manufacturers that highlight violative practices persist despite numerous published guidance documents.
