Marieke van Dalen
MARA Consultancy
Referent:innen
Maria da Graca Mata
Hovione
Dr. Marcel Goverde
MGP Consulting
Zielsetzung
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 EDQM, EMA, FDA, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance. The APIC Steering Committee has decided once again to offer this year’s APIC/CEFIC Global GMP & Regulatory API Conference as a hybrid event. The lectures will be held live in Vienna and streamed online so that you may choose freely how you wish to participate.
During the Conference updates from recent European and global authorities’ initiatives, activities and interpretations like EDQM’s support for initiatives to handle shortages, the update from EMA’s Quality Working Party and FDA’s expectations how to implement the Data Integrity requirements are provided. Hear from industry speakers sharing their approaches and best practices on all API related topics.
The Parallel Sessions are no workshops – they are practically oriented and supposed to support you in your daily work.
During the Conference updates from recent European and global authorities’ initiatives, activities and interpretations like EDQM’s support for initiatives to handle shortages, the update from EMA’s Quality Working Party and FDA’s expectations how to implement the Data Integrity requirements are provided. Hear from industry speakers sharing their approaches and best practices on all API related topics.
The Parallel Sessions are no workshops – they are practically oriented and supposed to support you in your daily work.
Hintergrund
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 EDQM, FDA, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.
The APIC Steering Committee has decided once again to offer this year’s APIC/CEFIC Global GMP & Regulatory API Conference as a hybrid event. The lectures will be held live in Vienna and streamed online so that you may choose freely how you wish to participate.
During the Conference, updates from recent European and global authorities’ initiatives, activities and interpretations like EDQM’s support for initiatives to handle shortages and FDA’s expectations on how to implement the Data Integrity requirements are provided. Hear industry speakers sharing their approaches and best practices on all API-related topics.
The Parallel Sessions are no workshops – they are practically oriented and supposed to support you in your daily work.
The APIC Steering Committee has decided once again to offer this year’s APIC/CEFIC Global GMP & Regulatory API Conference as a hybrid event. The lectures will be held live in Vienna and streamed online so that you may choose freely how you wish to participate.
During the Conference, updates from recent European and global authorities’ initiatives, activities and interpretations like EDQM’s support for initiatives to handle shortages and FDA’s expectations on how to implement the Data Integrity requirements are provided. Hear industry speakers sharing their approaches and best practices on all API-related topics.
The Parallel Sessions are no workshops – they are practically oriented and supposed to support you in your daily work.
Programm
Gesamtes Programm als PDF herunterladen
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
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 final dosage form manufacturer
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
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
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
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
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
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.
| ECA-Member*: | € 1596,- |
| Regular Fee*: | € 1680,- |
| EU/GMP Inspectorates*: | € 1260,- |
| APIC Member Discount*: | € 1512,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified API Production Manager"
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E-Mail: info@concept-heidelberg.de
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