27th APIC/CEFIC Global GMP & Regulatory API Conference - in Vienna or online
23/24 October 2024, Vienna, Austria
Course No. 21235
Speakers
Maria da Graca Mata
Hovione
Dr. Marcel Goverde
MGP Consulting
Marieke van Dalen
MARA Consultancy, The Netherlands
Background
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 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 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
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
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.
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more
Testimonials
Seminar Programme as PDF