20th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (All 3 Conference Days)

20th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (All 3 Conference Days)

Berlin, Germany

Course No 15879


Costs

Non-ECA/APIC Members: EUR 1990,--
ECA Members: EUR 1891,--
EU GMP Inspectorates: EUR 1493,--
APIC Members: EUR 1791,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Hugo Bonar, HPRA, Ireland
Hélène Bruguera, EDQM France
Sven-Erik Hillver, MPA, Sweden
Anabela Marcal, EMA, United Kingdom
Keith McDonald, MHRA, United Kingdom
Christina Meissner, AGES, Austria
Jean-Louis Robert, Chairman of the EMA QWP, United Kingdom

Marieke van Dalen, Aspen Oss B.V., The Netherlands
Manuel Figueiredo, Hovione, Portugal
Betsy Fritschel, Johnson & Johnson, USA
Valérie Guilbaut, Novacyl, France
Patrick Lefèvre, PCAS, France
Martijn Klop, Synthon, The Netherlands
Moheb Nasr, GSK, USA
Mechthild Sander, Alfred E. Tiefenbacher, Germany
Michael Toward, Johnson Matthey MacFarlan Smith, United Kingdom
Francois Vandeweyer, Janssen Pharmaceutica, Belgium
Hilde Vanneste, Janssen Pharmaceutica, Belgium
Victoria Waddington, United Kingdom

Objectives

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 FDA, 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 industry’s experiences with Quality Metrics followed by a presentation about the current status of the FDA/EMA Mutual reliance initiative. The following lectures are dedicated to the Regulatory Starting Materials, APIC’s revised GDP How to do Guide, industry’s experiences with continuous processing and counterfeiting APIs.

In the Joint GMP and the Regulatory Affairs part of the conference you will get an update on EDQM’s activities and hear presentations about the ICH Q11 Q&A from a health authority perspective, the current status of ICH Q12 and its benefit from the regulator’s and industry’s perspective, the QWP’s point of view regarding ICH Q3D, API variations and generic industry’s experience, FDA’s Division of Lifecycle APIs assessment of DMFs and case studies on post approval changes.

The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to practical experiences with ASMF assessment/worksharing, APIC’s revised Quality Agreement Guideline and Template and practical experiences with non EU/US authorities inspections. Further topics are dedicated to data integrity issues in the analytical environment and how to prevent them, APICs experience with supporting documentation for API filings in Emerging Countries and GMP requirements for biotech vs. biological APIs.

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

Programme

GMP Conference


Quality Metrics - Industry experiences so far
  • ISPE feed-back on the Quality metrics initiative implementation
  • Quality metrics reporting - benefits for the industry and patients
  • Constrains, difficulties, challenges to the industry
Betsy Fritschel, Johnson & Johnson, USA

FDA/ EMA Mutual reliance initiative: current status
  • Background of the initiative
  • Hurdles (to) overcome
  • Advantages for Industry, once signed
Anabela Marcal, Head of Compliance and Inspection Department EMA, United Kingdom

Regulatory Starting materials: a GMP perspective
  • Introduction / Recent trends
  • Regulatory Guidances and papers
  • Issues for Starting material selection
  • HA expectations
  • APIC TF
  • GMPs for Starting materials(manufacturing/analytical)
  • Auditing of Starting materials
  • Q&A
Francois Vandeweyer, Janssen Pharmaceutica, Belgium

GDP for APIs: the revised APIC How to do guide
Speaker from APIC Task Force(confirmed)
  • Legal framework of GDP for API and customers' expectations
  • How to comply with GDP requirements - API industry recommendations (focus on the How To Do Document)
  • How API manufacturer may address GDP compliance for product shipped under non-controlled conditions (Focus on position paper and product supply chain routes qualification strategy
)

Continuous processing: industry experience
  • First commercial continuous manufacturing facility in the EU for small molecule APIs
  • Technical, engineering, environmental and health and safety considerations
  • Regulatory issues and challenges
  • Future trends
Speaker from Ely Lilly, Ireland (confirmed)

Counterfeiting APIs: welcome to the real world!
Hugo Bonar, HPRA, Ireland

Open Q&A Session

Joint GMP and Regulatory Affairs Day


Parallel Sessions, Part A

Session 1:
ASMF assessment/ worksharing: practical experience
How the European ASMF worksharing procedure works
Update on the current status
Practical experiences of an ASMF holder
Martijn Klop, Synthon, The Netherlands

Session 2:
Quality agreements: revised APIC guideline and template
Quality Agreements between API and drug manufacturers: legal/regulatory requirements and customer expectations
The revised APIC guideline and template: what has changed?
How to best use the APIC standard template?
Patrick Levèfre, PCAS, France

Session 3:
Inspections by non EU / US authorities: practical experiences
Inspections from non-ICH countries are increasing
What are the typical topics
Are there special things to consider?
Marieke van Dalen, Aspen Oss B.V., The Netherlands

Parallel Sessions, Part B

Session 4:
APICs 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; Manuel Figueiredo, Hovione, Portugal

Session 5:
Data integrity: how to prevent problems in the analytical environment
What does data integrity mean? (mainly for ALCOA principles, data integrity continuum)
Legal framework for data integrity requirements
What is needed to ensure data integrity (validation/qualification of CS and automated systems, quality system, good documentation practices, quality culture….)
How to address data integrity issues within the laboratory from simple equipment to computerized systems
Valérie Guilbaut, Novacyl, France (APIC Task Force on Data Integrity)

Session 6:
GMP requirements for biotech vs. biological APIs
Applying biotech regulations to biologicals
Is separate guidance needed for extraction products?
Christina Meissner AGES, Austria

Update on EDQM activities
The work programme of the Ph. Eur and how to take part in it
Recent developments for Ph. Eur texts
The CEP procedure: how to build a good CEP application according to most recent requirements
The EDQM inspection programme for APIs manufacturers, where are we today?
Hélène Bruguera, EDQM France

ICH Q11 Q&A, a health authority perspective
Development and manufacture of drug substance - both synthetic and biological origin - according to ICH Q11
Selection and justification of starting materials
Further clarification and guidance by the ICH Q11 Q&A document
Selection of the starting material for a synthetic manufacturing process and its impact on industry and regulators
The objective of the ICH Q11 Q&A
Status update on the Q&A document.
Keith McDonald MHRA, United Kingdom

ICH Q12: Benefit and Challenges from a Regulatory Point of View
Jean-Louis Robert, Chairman of the EMA QWP, United Kingdom

ICH Q12: What would be the benefit for the industry?
Industry perspective on how ICH Q12 will impact on the post approval change management across product lifecycle.
Which are the regulatory tools and enablers that will promote innovation and continuous improvement?
Moheb Nasr, GSK, USA

Open Q&A Session

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 ICH Q3D global implementation and the generic industry's view as well as the QWP's perspective. Presentations about the FDA's Division of Lifecycle APIs assessment of DMFs and case studies of post approval changes will round off the Regulatory Affairs Conference programme.

ICH Q3D global implementation: the generic industry's view
  • What information is needed from the API supplier and why
  • Questionnaires
  • Daily dose considerations
Mechthild Sander, Alfred E. Tiefenbacher, Germany

ICH Q3D - QWP's point of view
Sven-Erik Hillver, Medical Products Agency, Sweden

Generic industry's experience with API variations
Speaker to be named

FDA's Division of Lifecycle APIs assessment of DMFs
Speaker to be named

Post approval changes: a case study
  • Challenges with a global product
  • Timelines
  • Implementation of the change
Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V., The Netherlands

Final Discussion, Closing Remarks

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