18th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients (All 3 Conference Days)

4-6 November 2015, Amsterdam, The Netherlands

Course No. 9300



Hélène Bruguera
EDQM, France
Rosimeire Pereira Alves da Cruz
ANVISA, Brazil
Dulcelina Mara Pereira Said
ANVISA, Brazil
Ewan Norton
MHRA, United Kingdom
Jean-Louis Robert
Chairman of the EMA QWP, United Kingdom
Alex Viehmann
Marieke van Dalen
Aspen Oss B.V., The Netherlands
Betsy Fritschel
Johnson & Johnson, USA
Uwe Fischbeck
Merck, Germany
Rainer Nicolai
Hoffmann-La Roche, Germany
Koen Nauwelaerts
European Generic Medicines
Association, Belgium
Luisa Paulo
Hovione, Portugal
Janeen Skutnik-Wilkinson
Pfizer, USA
Anthony Storey
Pfizer, United Kingdom
Florent Trouillet
BASF, Switzerland
Francois Vandeweyer
Janssen Pharmaceutica, Belgium
Hilde Vanneste
Janssen Pharmaceutica, Belgium
Lore Vignoli
Roquette Freres, France
Victoria Waddington
Macfarlan Smith Limited
A Johnson Matthey Company
Tim Watson
Pfizer, USA


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.


GMP Conference

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

Panel Discussion

Joint GMP and Regulatory Affairs Day

Parallel Sessions, Part A

Session 1:
Quality Agreements
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)

Session 2:
Post approval change management protocol
Guidelines on post approval change management protocols
Benefit for Industry
Practical implications
Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V.

Session 3:
GMP compliant manufacture of highly potent APIs
general concepts and technical details.
hygienic design piping class for chemicals
special reactor design
isolator technologies
cleaning of equipment
Rainer Nicolai, F. Hoffmann-La Roche

Coffee Break

Parallel Sessions, Part B

Session 4:
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

Session 5:
Emerging Markets - current regulatory requirements
Regulatory mapping
Manufacturers' experiences sharing
Current and forthcoming challenges
Lore Vignoli, Regulatory Affairs, Roquette Freres

Session 6:
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
Regulatory implications
Key aspects of the guideline
Next steps
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

Panel Discussion

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


This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more

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