22nd APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (All 3 Conference Days)
(Im Auftrag der APIC/CEFIC)

22nd APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (All 3 Conference Days) (Im Auftrag der APIC/CEFIC)

Prague, Czech Republic

Seminar Nr. 17213


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de


Authority Speakers:
Hélène Bruguera, EDQM France
Gabriel Ramos Ferronatto, ANVISA, Brazil
Bastiaan Venhuis, RIVM, The Netherlands

Industry Speakers:
Landry Le Chevanton, DSM Switzerland
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Jacky van Gompel, Janssen Pharmaceutica, Belgium
Daniella van Gauwbergen, Janssen Pharmaceutica, Belgium
Charles Gibbons, Abbvie, Ireland
Patty IJjzermans, Aspen Oss B.V., The Netherlands
Sabina Jurca, Sandoz, Slovenia
Dirk Overroedder, Cilag, Switzerland
Georg Strasser, Cilag, Switzerland
Florent Trouillet, Siegfried, Switzerland
Dieter Vanderlinden, Aji Bio-Pharma Services, Belgium
Francois Vandeweyer, VDWcGMP Consultancy, Belgium


The APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Europe’s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from EMA, EDQM, National Authorities, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.

The GMP Conference, of which the final part 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 their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP.

The conference will be opened by a presentation about EMA’s current activities in 2019 followed by a presentation about non sterile APIs used in sterile drug products. The following lectures are dedicated to the Supply chain security for APIs, Anti-counterfeiting activities in Europe, relevant aspects of risk based assessment of indirect materials and qualification of suppliers and how to deal with avoidable and unavoidable particles in APIs.

In the Joint GMP and the Regulatory Affairs part of the conference you will get to know about FDA’s current practice of DMF assessment, the consequences of Brexit for APIs, how to prepare pre-approval inspections and an update on Ph.Eur. and CEP procedures.

The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to Data Integrity risk assessments, practical experiences with API filings in Emerging Countries, biological extraction products, regulatory hurdles and opportunities, feedback on the 2nd revision of ICH M7 Q&A and GMPs for manufacture of clinical trial material from a CMO’s perspective.

The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.


GMP Conference

EMA – Current activities
EMA speaker to be named

Non sterile APIs used in sterile drug products –industry best practice
  • General Overview / industry situation
  • Guidelines/Expectations
  • Building Microbiological Quality into low bio-burden APIs
  • Challenges in assuring Microbiological Quality into low bio-burden API’s
  • Control strategies for:

    - Facility design

    - Facility operations

    - Environmental monitoring

    - Contamination risk reduction
  • Conclusion
Francois Vandeweyer, VDWcGMP Consultancy, Belgium

Supply chain security for APIs
  • Complexity of API manufacturing and distribution supply chains
  • APIC guidance documents on how to manage risks in API distribution chains
  • Quality agreements and management of deviations within distribution processes
  • Risk based approaches for temperature conditions during distribution
Daniella van Gauwbergen, Janssen Pharmaceutica, Belgium

Minimizing Public Health Risks posed by Falsified Medicines
  • Activities in Europe (CMED)
  • Challenges in the supply chain
  • The consumers’ perspective
Bastiaan Venhuis, National Institute for Public Health and the Environment (RIVM), The Netherlands

Risk based assessment of indirect materials and qualification suppliers
  • Regulatory requirements/expectations

  • Composition of a matrix of approved IM suppliers
  • Way forward to a risk based classification of IM
  • Process to qualify IM and suppliers based on the risk categorization
  • Process to monitor IM and suppliers
  • Attention points at implementation (impact and resources)
Georg Strasser, Cilag, Switzerland

Avoidable and Unavoidable Particles in APIs
  • Expectations, Guidelines, Facts & Figures
  • Proactive Prevention vs. Mitigation
  • Control & Improvement Strategies
Dirk Overroedder, Cilag, Switzerland

Joint GMP and Regulatory Affairs Day

Parallel Sessions, Part A

Session 1:
Data integrity – practical examples on how to perform gap analysis and risk assessments
  • How to approach data integrity using APIC guide’s methodology – Identify, assess and remediate any potential data integrity risks within your company

  • Discussion of some practical examples in a manufacturing and lab environment
Dieter Vanderlinden, Aji Bio-Pharma Services, Belgium,
Charles Gibbons, Abbvie, Ireland

Session 2:
APIC’s Experience with Supporting Documentation for API filings in Emerging Countries
  • Emerging Countries Interest Group - What is it? What do we do?
  • Experience when using an Active Substance Master File (ASMF) / Drug Master File (DMF)
  • Experience when using a Certificate of the European Pharmacopoeia (CEP)
Speaker to be named

Session 3:
Biological extraction products
  • specifics of extraction products
  • applicability of guidelines
Patty IJjzermans, Aspen Oss, The Netherlands

Parallel Sessions, Part B

Session 4:
Regulatory hurdles and opportunities
  • APIC tips and trics for dealing with regulatory issues
Marieke van Dalen, Aspen Oss, The Netherlands

Session 5:
Feedback on the second revision of the Q&A section of ICH M7 guideline
  • New compound list and ADE’s
  • Quality related Q&A’s
  • Safety related Q&A’s
Jacky van Gompel, Janssen Pharmaceutica, Belgium

Session 6:
GMPs for Manufacture of clinical trial material – a CMO’s perspective
  • Regulatory requirements vs. customer expectations
  • Focus on development vs validation readiness (risk management, documentation, cleaning, changes)
  • Cases studies on challenges in daily operations
Florent Trouillet, Siegfried (Evionnaz), Switzerland

Update on ANVISA activities
  • regulatory activities
  • Inspection activities
  • International cooperation
Gabriel Ramos Ferronatto, ANVISA, Brazil

Brexit – Consequences
Speaker to be named

Pre-Approval Inspections: How to prepare best practice
Speaker to be named

FDA’s current practice for DMF assessment
  • Division of Lifecycle API : role and responsibilities
  • DMF assessments: how to improve first time right
  • GDUFA: some key figures, plans for improvement
FDA confirmed

Regulatory Affairs Conference

After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of registration procedures in China, Japan and Brazil as well as, aspects of world wide API assessment.

The Ph. Eur and CEP procedure in 2019
  • The Ph. Eur 10th edition and its priorities for the future
  • Links between the Ph. Eur and CEPs
  • Update on CEP guidelines and procedures
  • Improving the use of CEPs to support in marketing applications
  • Impact of the Brexit on EDQM activities
Hélène Bruguera, EDQM France

Registration in China
  • Current China regulatory landscape
  • API registration requirements and procedures
  • Recent experience of API industry with China registrations
Sabina Jurca, Sandoz, Slovenia

Registrations in Japan: latest update
MHLW confirmedSpeaker to be named

API assessment world wide
  • What are the similarities
  • Differences in format and content
  • Change control procedures
Marieke van Dalen, Aspen Oss, The Netherlands

Final Discussion, Closing Remarks


GMP Seminare nach Thema

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