2nd European Conference on Pharmaceutical Excipients - APV

2 nd <strong>European</strong> <strong>Conference</strong> on Pharmaceutical Excipients
Excipients in a changing world
© Berlin Tourismus & Kongress GmbH
Keynote Speakers
Richard Andrews, Operations Manager GMP/GDP, MHRA, United Kingdom
Jörg Breitkreutz, Professor at Heinrich Heine University Duesseldorf, Germany
Abhay Gupta, Senior Staff Fellow at FDA, United States
Steven Hewitt, Sanbec Consulting Ltd., United Kingdom
Karl Kolter, Head of Pharmaceutical Excipients Research and Development at BASF, Germany
Gianluca Minestrini, Head of Global Supply Chain Quality System at F. Hoffmann-La Roche, Switzerland
Allan Whiston, Chartered Quality Professional (CQP) at QA Resolutions Ltd, United Kingdom
International Association for Pharmaceutical Technology
www.apv-mainz.de
26 th to 27 th November 2012
Berlin, Germany
Course No. 3105
Target Group
This conference is intended for professionals working in
development, manufacture and quality,
distribution and sales,
qualification of suppliers,
application and control
of pharmaceutical excipients for medicinal products. The conference is also intended for
members of regulatory authorities and purchasing departments

2 nd <strong>European</strong> <strong>Conference</strong> on Pharmaceutical Excipients
Programme
Monday, 26 th November 2012 10:00 to 18:30 h
Opening/Welcome
Dr. Hubertus Folttmann
Head of Association Activities – Pharma Ingredients &
Services
BASF SE, Germany
Dr. Frank Milek
Head of GMP and SHEQ Operations
Aug. Hedinger GmbH & Co. KG, Germany
FMD Implementation related to excipient compliance
and auditing (Directive 2011/62/EU)
Richard Andrews
Operations Manager GMP/GDP
Medicines and Healthcare products Regulatory Agency
(MHRA), United Kingdom
Excipient issues in drug product quality: An FDA
Perspective
Abhay Gupta, Ph.D. (Speaker requested)
Senior Staff Fellow
FDA-CDER, Division of Product Quality Research,
United States
GMP and GDP for pharmaceutical excipients – How
IPEC guides contribute
Allan Whiston
Chartered Quality Professional (CQP)
QA Resolutions Ltd, United Kingdom
What does a global pharmaceutical company expect
from excipient suppliers in the light of current
regulation?
Current regulatory focus areas
Excipient user expectations
Impact on business relationships
Dr. Gianluca Minestrini
Head of Global Supply Chain Quality System
F. Hoffmann-La Roche Ltd, Switzerland
Auditing and certification of Excipient suppliers
Why audit Excipient suppliers?
What standards/regulations?
Audit or certification?
Audit program overview
Dr Steven Hewitt
GMP Advisor
Sanbec Consulting Ltd.,
United Kingdom
Risk Assessment to determine the level of GMP according
2011/62EU – an industry approach
Frithjof Holtz
Director Advocacy
Pharm Chemicals Solutions, Merck Millipore Division,
Merck KGaA, Germany
Panel discussion
City tour at night and networking dinner
Tuesday, 27 th November 2012 8:30 to 16:30 h
GET A PRACTICAL APPROACH
Implementing 'risk management' into a QMS, but
how?
What is / is not 'risk'?
Culture and mindset
Managing a risk: objective and limitations
Processes and systems
Dr. Gerd Fischer
Head of Operations Regulatory Intelligence
Corporate Division Quality, Boehringer Ingelheim GmbH,
Germany
Design of an excipient stability testing programme
according to the IPEC Stability Guide
Principles and content of the IPEC Stability Guide
Practical approach for implementation
Tanja Natterer
Quality Control Manager
Aug. Hedinger GmbH & Co. KG, Germany
Excipient quality control and COAs – best fit between
supplier and user Challenges and advantages of COA
acceptance
Expectations of pharmaceutical companies
Excipient supplier qualification/certification
Supplier management and related systems
Dr. Uwe Müller
Launch Management
Boehringer Ingelheim Pharma GmbH & Co KG,
Germany

Novel Excipients – from scratch to launch
Definitions of types of new excipients
Description of the development process
Particular requirements for novel excipients incl. toxicology
Major challenges and sucess factors
Dr. Karl Kolter
Head of R&D Pharma Ingredients
BASF SE, Germany
<strong>European</strong> Pharmacopoeia Perspective on functionality-related
characteristics of Pharmaceutical Excipients
Performance of excipients
Physical and chemical properties
Specifications
Regulatory guidance
Dr. Pascal Furrer, University of Geneva, Switzerland
Investigation of modified release performance design
space and batch-to-batch reproducibility
The impacts of atypical %HPO substitution levels (6.0 to
11.4%) on modified release performance.
Expand design space boundaries during formulation
development.
How to predict modified release performance before a
particular hypromellose batch is even used in an established
matrix formulation.
Dr. Amina Faham
Senior Pharmaceutical Application Manager
Dow Europe GmbH, Switzerland
Specific requirements for paediatric medicines
Fatal outcomes in the past
Age-related toxicity
Labelled excipients vs. non-specified ingredients
STEP database by EuPFI
Prof. Dr. Jörg Breitkreutz
Professor at Heinrich-Heine-University Düsseldorf,
Germany
Final Discussion and closing remarks
Social programme
Sunday, 25 th November 2012, 19.00 h
Stroll through the Christmas market and afterwards
warm-up with a glass of mulled wine
Monday, 26 th November 2012, 19.00 h
City tour at night and networking dinner
Dear Colleagues,
We invite you to attend the 2 nd <strong>Conference</strong> on Pharmaceutical
Excipients to be held in Berlin, 26 th – 27 th November
2012. IPEC Europe and APV have jointly developed a programme
covering the current “hot topics” in the field of
pharmaceutical excipients. IPEC Europe represents manufactures,
distributors and users of excipients. All topics
relevant to pharmaceutical excipients are on IPEC’s agenda
and have therefore influenced the programme of this
conference. This year, we have not only the changes in
<strong>European</strong> regulation for pharmaceutical excipients, but also
many other topics such as supplier qualification and auditing,
excipient stability and quality control, Quality by
Design, as well as excipient application related aspects e.g.
development of novel excipients and excipients in paediatric
dosage forms keep the association busy in its activities.
All these topics have been collected and put together as a
programme to provide updates on these subjects and to
provide a platform for interactive discussions.
We believe that this conference will be of interest and value
for all professionals involved in the manufacturing, distribution
and use of pharmaceutical excipients and the associated
regulation.
It will be a great pleasure for us to welcome you in Berlin
on behalf of IPEC Europe and APV
Frank Milek
Chair to IPEC Europe
Hubertus Folttmann
Board Member of APV and IPEC Europe

Date
Course No. 3105
from 26 th Nov. 2012 10:00
to 27 th Nov. 2012 16:30
Location
RAMADA Hotel Berlin-
Alexanderplatz****
Karl-Liebknecht-Straße 32
Berlin, Germany
Phone: +49 30 3010411-0
Fax: +49 30 3010411-550
Registration fee
APV/ipec member 1360 EUR
Non-member 1490 EUR
(free of VAT according to § 4,22
UStG)
Coffee breaks, luncheons,
dinner and proceedings included.
Accounts
Dresdner Bank AG Mainz
Account No. 2 325 159 00
Bank Code 550 800 65
Postbank Frankfurt/M.
Account No. 127 35-606
Bank Code 500 100 60
Registration
by fax +49 6131 9769-69
By postal service to:
APV Arbeitsgemeinschaft für
Pharmazeutische Verfahrenstechnik e.V.
Kurfürstenstraße 59
D-55118 Mainz
Registration
APV-Geschäftsstelle
Kurfürstenstraße 59
55118 Mainz/Germany
Phone: +49 6131 9769-0
Fax: +49 6131 9769-69
e-mail: apv@apv-mainz.de
You will receive a confirmation
of your registration with the
invoice.
Members of authorities pay half
of the APV member’s and nonmember’s
registration fee
respectively.
Hotel reservation
RAMADA Hotel Berlin-
Alexanderplatz****
Karl-Liebknecht-Straße 32
Berlin, Germany
Phone: +49 30 3010411-0
Fax: +49 30 3010411-550
Participants should make their
own hotel reservation referring
to the APV seminar.
Deadline for special conference
rate: 15 th October, 2012.
Special rate:
Single room incl. breakfast buffet
from EUR 109,00 per night.
Mainz, June 2012
Course No. 3105
2 nd <strong>European</strong> <strong>Conference</strong> on Pharmaceutical Excipients
Berlin, Germany, from 26 th to 27 th November 2012
Title, First Name, Name
Company Name
Company Address
Phone Fax
e-mail Address
Position in Company Department
APV Member Non-member
Date Signature