Amsterdam, The Netherlands
Course No 9300
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Rosimeire Pereira Alves da Cruz
Dulcelina Mara Pereira Said
MHRA, United Kingdom
Chairman of the EMA QWP, United Kingdom
CDER, US FDA
Marieke van Dalen
Aspen Oss B.V., The Netherlands
Johnson & Johnson, USA
Hoffmann-La Roche, Germany
European Generic Medicines
Pfizer, United Kingdom
Janssen Pharmaceutica, Belgium
Janssen Pharmaceutica, Belgium
Roquette Freres, France
Macfarlan Smith Limited
A Johnson Matthey Company
Objectives of the Conference
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 the European and US Authorities on recent 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 an update of FDA’s current quality initiatives followed by a presentation about the industry’s view on API Quality Metrics. Four more presentations are dedicated to the current Inspection findings with respect to data integrity, the contribution of the API industry to avoid drug shortages, the
new GDP requirements and first experiences with the new ICH Q3D guideline about elemental impurities.
In the Joint GMP and Regulatory Affairs part of the conference you will hear presentations about the implications of the ICH Q12 Guideline for the API industry and about an update from Health Canada regarding API regulatory requirements. Two more lectures about quality and regulatory expectations of the API industry customers and activities regarding ICH Q11 will round off this part of the conference.
The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to current regulatory challenges, special API related aspects of emerging markets, the manufacture of highly potent APIs, quality agreements and the implementation of the new Q/ Q&A document.
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.
An update on current FDA initiatives including Quality Metrics, Quality Culture and GDUFA
Introducing CDER's new Office of Pharmaceutical Quality / Office of Surveillance
Overview and status of FDA's Quality Metrics Program
How quality metrics can support CDER surveillance
Overview of GDUFA program objectives and accomplishments
Alex Viehmann, CDER, US FDA
API Quality Metrics - an Industry view
Why FDA is focusing on Quality Metrics, where they get the authority to do so, how they say they will use the data collected
Current expectations for what data will be expected
Learnings from participation in pilots both internal and multi-company
Likely impact to API industry
Betsy Fritschel, Regulatory Compliance, Johnson & Johnson, USA
Current inspection findings: Data Integrity
What is data integrity?
Why is it so important?
What are the authorities/Inspectors doing to identify this issue?
What can industry do to prevent such issues?
Ewan Norton, GMDP Inspector, MHRA
How to implement the new GDP requirements
The new EU GDP Guideline: What is actually new ?
Experiences with the implementation of GDPs for APIs
Customer and authority expectations
APIC How-to-do Document on GDPs
Frithjof Holtz, MM-Q-Regulatory Services, Merck KGaA
ICH Q3D - what is the impact of this guideline to the API Industry?
Why ICH Q3D isn't a testing guidance
What the guidance is and is not
What companies need to do to prepare for implementation
What this means ( and doesn't mean) for API manufacturers
Suggestions for how companies should interact with their suppliers and customers
Janeen Skutnik-Wilkinson, Pfizer, USA
Joint GMP and Regulatory Affairs Day
Parallel Sessions, Part A
Quality Agreements between the API manufacturer and its customers: scope and legal requirements
Format and content of Quality Agreements
Successfully negotiating Quality Agreements: points for consideration
Further aspects (e.g. maintenance, multiple sites/parties)
APIC Quality Agreement Guideline and Templates
Florent Trouillet, Quality Department, BASF Pharma (Evionnaz)
Post approval change management protocol
Guidelines on post approval change management protocols
Benefit for Industry
Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V.
GMP compliant manufacture of highly potent APIs
general concepts and technical details.
hygienic design piping class for chemicals
special reactor design
cleaning of equipment
Rainer Nicolai, F. Hoffmann-La Roche
Parallel Sessions, Part B
Q7 Q&A - how to implement
Overview of the ICH Q7 Q and A document
Benefits of the document to Industry
Good practices/how to do &interpret the Q and A document
Question and Answer open discussion session how to implement Q7/current concerns and expectations
Anthony Storey, Pfizer, United Kingdom; Francois Vandeweyer, Janssen Pharmaceutica, Belgium
Emerging Markets - current regulatory requirements
Manufacturers' experiences sharing
Current and forthcoming challenges
Lore Vignoli, Regulatory Affairs, Roquette Freres
Current regulatory issues and hurdles
CEP latest developments
ASMF latest developments
Recent experiences with emerging markets
Hilde Vanneste, CMC Regulatory Affairs, Janssen Pharmaceutica; Victoria Waddington, Regulatory Compliance, Macfarlan Smith Limited A Johnson Matthey Company
ICH Q12 - current status of life cycle management
Scope of the guideline and major objectives
Impact on the industry - benefits
Key aspects of the guideline
Luisa Paulo, Hovione
Quality and regulatory expectations of the API industry customers
API supply chain Regulatory issues : Concerns regarding increasing GMP information in the regulatory dossier
Distribution of API : GDP
Expectations regarding the implementation of ICH Q3D on metal impurities
API starting materials
Koen Nauwelaerts, European Generic Medicines Association
Update on activities regarding ICH Q11
Why the need for a IWG Q11 activity?
Why the concern over the definition of a RSM
Work of the ICH Q11 IWG and expected outcomes
What this activity will bring to industry and authorities
What are the concerns for an industry perspective
Tim Watson, CMC Advisory Office, Pfizer, USA
Regulatory Affairs Conference
After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight latest developments of EDQM activities and initiatives, and registration requirements of APIs in Emerging Markets. A presentation about the activities of the EMA Quality Working Party with focus on aspects of Quality by Design will round off the Regulatory Affairs Conference programme.
Last development of Brazilian regulation for Active Substances
Upcoming API registration process
Focus on RDC 60 and requirements for active substances
Rosimeire Pereira Alves da Cruz; Dulcelina Mara Pereira Said, ANVISA, Brazil
Registration requirements for APIs in South Korea
Working towards harmonisation and regulatory convergence - the experience of EDQM
Update on the Ph. Eur activities including new monographs, international harmonisation, good pharmacopoeial practice
Implementation of new ICH guidelines in the CEP procedure (ICH Q11, Q3D, M7)
Worksharing initiatives for ASMF and CEPs (EU ASMF, IGDRP)
The EDQM inspection programme and international collaboration in the area of API inspections
Hélène Bruguera, Deputy Head/Division Certification of Substances, EDQM
EMA QWP - aspects of Quality by Design
Jean-Louis Robert, Chairman of the EMA QWP
Final Discussion, Closing Remarks