21st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (RA Part)
(Im Auftrag der APIC/CEFIC)

21st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (RA Part) (Im Auftrag der APIC/CEFIC)

Budapest, Hungary

Seminar Nr. 16449


Kosten

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

Sprecher

Hélène Bruguera, EDQM France
Maria Filancia, EMA, United Kingdom
Rainer Gnibl, EU-GMP Inspector, Germany
Landry Le Chevanton, DSM, Switzerland
David Cockburn, formerly European Medicines Agency (EMA)
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Joerg Gampfer, Hovione, Portugal
Markus Goese, F. Hoffmann-La Roche, Switzerland
Oksana Golycheva, Janssen Pharmaceutica, USA
René van Herpen, Aspen Oss B.V., The Netherlands
Martijn Klop, Synthon, The Netherlands
Danny de Scheemaecker, Janssen Pharmaceutica, Belgium
Michael Toward ,Johnson Matthey MacFarlan Smith, United Kingdom
Dieter Vanderlinden, Ajinomoto OmniChem, Belgium
Francois Vandeweyer, Janssen Pharmaceutica, Belgium
Guy Villax, Hovione, Portugal

Zielsetzung

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 FDA latest initiatives in 2018 with special focus on the EU-US-MRA followed by a presentation about current findings from EU-GMP inspections at EU- & Asian API-manufacturers. The following lectures are dedicated to the Brexit and the consequences for the API industry, the latest development of the EU-US-MRA, the current regulatory landscape in Canada and Data Integrity aspects in the API production area.

In the Joint GMP and the Regulatory Affairs part of the conference you will get to know what authorities can do about drug shortages, the latest requirements for API registrations in Eastern Europe an update on ANVISA’s international cooperation and on EDQM’s activities and initiatives. Furthermore you will hear presentations about the EU ASMF assessment worksharing, Industry point of view of the ICH Q12 guideline and recent developments regarding API regulations in China. The conference will be rounded off by a presentation about the way towards global harmonization of regulatory requirements.

The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to practical experiences with API filings in Emerging Countries, risk based audits of regulatory starting materials, statistical approaches to process validation, ICH Q3D consequences for APIs, Drug Substance control strategies and aspects of fraud in the supply chain of APIs and raw materials.

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

Programm

Joint GMP and Regulatory Affairs Day


Parallel Sessions, Part I

Session 1:
APIC‘s experience with supporting documentation for API filings in Emerging Countries
  • Emerging Countries Interest Group – What is it and what do we do?
  • Supporting documentation required when using a CEP.
  • Supporting documentation required when using a DMF.
Michael Toward, Johnson Matthey MacFarlan Smith, United Kingdom

Session 2:
Risk based use of audits in the life cycle approach of a regulatory starting material -
industry perspective
  • What is needed to evaluate an RSM?
  • What part does an audit play in the evaluation and lifecycle approach of the RSM?
  • What are the required standards needed for manufacture of a RSM and hence what and how you audit these requirements?

  • Use of Q9 risk assessments in the maintenance of the RSM life cycle

Francois Vandeweyer, Janssen Pharmaceutica, Belgium

Session 3:
Statistical approach to process validation
  • Pros and cons of current (draft) guidance
  • EMA Reflection paper on statistical methodology, FDA guidance and Q5E
  • Consequences for industry
René van Herpen, Aspen Oss B.V., The Netherlands

Parallel Sessions, Part II

Session 4:
ICH Q3D consequences for APIs
  • Status of implementation of ICH Q3D
  • Update on ICH Q3D Working Group
Landry Le Chevanton, DSM, Switzerland

Session 5:
Drug Substance Control Strategy
  • Elements of a Control Strategy
  • Identification of Criticality and designing Controls
  • Continuous Improvement – A lifecycle approach to Control Strategies
Joerg Gampfer, Hovione, Portugal

Session 6:
Fraud in the supply chain
  • Case studies
  • When things go wrong, what matters is how you deal with it
  • Quality culture versus compliance
Guy Villax, Hovione, Portugal

What can authorities do about drug shortages?
  • Who is responsible for medicines supply?
  • What causes medicines shortages?
  • Which causes can be influenced by regulatory authorities?
  • Examples of practical measures
  • Is there a need for industry guidance?
David Cockburn, formerly European Medicines Agency (EMA)

API registrations in Eastern Europe
Oksana Golycheva, Janssen Pharmaceutica, USA

ANVISA: latest international cooperation
ANVISA speaker

Update on EDQM activities
  • Preparing the 10th edition of Ph. Eur – hot topics
  • Update on the CEP procedure
  • Changes to revisions of CEPs
  • Update on EDQM inspections
Hélène Bruguera, EDQM France

Regulatory Affairs Conference


Objectives
After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of the EU ASMF assessment worksharing, industry’s perspective on ICH Q12, the latest Chinese API regulations and International harmonization programs.

EU ASMFs: worksharing and eCTD
  • The EU ASMF assessment worksharing
  • eCTD submissions in the EU
Martijn Klop, Synthon, The Netherlands

ICH Q12 - Industry point of view
  • Established conditions

    - What does it mean?

    - How to define?

    - Expected impact on variations
  • PACMP – Post Approval Change Management Protocols

    - Purpose

    - Why and how a PACMP can help?
  • PLCM – Product Life Cycle Management: Purpose
  • Why and how it should be included in the CTD?
Markus Goese, F. Hoffmann-La Roche, Switzerland

API regulations - what is happening in China?

Global harmonization: Utopia?
  • International harmonization programs
  • Current status
  • Way forward
Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V., The Netherlands

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