Headline
Connecting People, Science and Regulation®
2008 PDA/EMEA Joint Conference
European GMP:
Current Issues and
Future Developments
18-21 February 2008
Budapest, Hungary
Conference Exhibition Training Courses Workshop |
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20-21February 2008
20-21February 2008
18-19 February 2008
18-19 February 2008
foto: Elias Bizannes
www.pda.org/emea2008
Register by
14 December 2007
and SAVE! Headline
Table of Contents
3
A Message from the Program Planning Committee Chairs
4
Event Schedule-at-a-Glance
5
Conference Agenda
10
PDA TRI Training Courses
12
PDA Workshop on Cleaning and Disinfection
13
General Information
14
Exhibition & Sponsorship Opportunities
15
Registration Form
16
PDA Europe Conference & Event Calendar 2007/2008
2008 PDA/EMEA
Joint Conference
Program Planning
Committee
Co-Chairs
Stephen Bellis,
CMC Biopharmaceuticals,
Denmark
David Cockburn,
EMEA Inspections Sector
Lothar Hartmann,
F. Hoffmann – La Roche,
Switzerland
Regulatory Authorities
Industry
PDA Staff
Emer Cooke,
EMEA Inspections Sector
Véronique Davoust,
Pfizer, France
Robert Dana,
PDA
Timea Molnarne
Lakatost,
Vet Products Agency,
Hungary
Thomas Linz,
Bayer Schering Pharma AG,
Germany
Frederike Graeper,
PDA Europe
Jacques Morénas,
AFSSAPS, France
Sabine Paris,
ZLG, Germany
Eija Pelkonen,
NAM, Finland
Tim Marten,
AstraZeneca,
United Kingdom
Morten Munk,
CMC Biopharmaceuticals,
Denmark
Liam Murphy,
Amgen, Ireland
Claudia Nardini,
Kedrion, Italy
Tesh Patel,
Abbott Laboratories,
United Kingdom
Georg Roessling,
PDA Europe
Jim Lyda,
PDA Europe
Stephen Bellis,
David Cockburn,
Lothar Hartmann,
CMC Biopharmaceuticals
EMEA Inspections Sector
F. Hoffmann – La Roche
A Message
from the Program Planning Commit tee Chairs
Dear Colleagues,
We are pleased to present to you the brochure of the 2008 PDA/EMEA Joint Conference, European GMP:
Current Issues and Future Developments. In your hands you hold the map to an unusual and unique opportunity. Waiting for you is a valuable and comprehensive conference covering the current and future GMP
issues for manufacturers, distributors and importers of medicinal products in Europe. The ‘Thanks’ for this
stellar accomplishment of putting together such an exciting program goes to the energetic program planning committee with members from the regulatory authorities and the industry (see accompanying listing
of members).
The agenda is ambitious with eight topical tracks and three plenary sessions. The fast evolving European
regulatory environment will be covered by a wide range of speakers, including industry experts who will
share their experience and knowledge. Most importantly, we have an extraordinary number of speakers
from EMEA, the European Commission and the national authorities. Rarely have so many officials from so
many authorities across Europe committed to present their views and participate in discussions on evolving
GMP. And never has interaction with European inspectors been this convenient.
While you are with us we invite you to enjoy the delights of Budapest. The food is great, the local transportation convenient, and there is much this historic European city has to offer.
If keeping current and informed regarding GMP is part of your job, then you will not want to miss the
2008 PDA/EMEA Joint Conference.
See you in Budapest in February 2008.
Stephen Bellis,
CMC Biopharmaceuticals
David Cockburn,
EMEA Inspections Sector
Lothar Hartmann,
F. Hoffmann - La Roche
Event Schedule-at-a-Glance
Headline
Sunday, 17 February 2008
16:00 – 20:00
Pre-registration for all events listed below
Monday,
18 February 2008
Tuesday,
19 February 2008
Wednesday,
20 February 2008
Thursday,
21 February 2008
Training Courses
Training Courses
Conference/Exhibition
Conference/Exhibition
08:00 – 09:00
Registration
08:00 – 09:00
Registration
07:00 – 08:30
Registration and
Welcome Coffee
07:00 – 08:30
Registration and
Welcome Coffee
09:00 – 16:30
09:00 – 16:30
08:30 – 12:15
08:30 – 12:00
ICH Q10 and its Potential Impact
on the Pharmaceutical Industry
– NEW COURSE!
Risk-Based Approach and Risk
Management in Pharmaceutical
Manufacturing Processes
Plenary Session 1
Concurrent Sessions
The European Environment
Session 5
Regulatory Quality
Drug Registration in Europe
– An Insightful View
– NEW COURSE!
Briefing Meetings, Scientific
Advice/Protocol Assistance,
Pre-Submission Meetings with
EMEA – When to Do What and
How to Prepare
– NEW COURSE!
12:15 – 13:15
Lunch Break
Session 6
Starting Materials
Preparing for and Passing a
European or United States GMP
Inspection (Day 1)
Quality System Strategies for
Investigational Drugs (Day 1)
Preparing for and Passing a
European or United States GMP
Inspection (Day 2)
Quality System Strategies for
Investigational Drugs (Day 2)
Session 7
GMP Inspections
13:15 – 14:30
Plenary Session 2
Survey of New, Revised and
Pending European Guidance
15:00 – 17:00
Concurrent Sessions
Session 8
Investigational Medicinal
Products (IMPs)
12:00 – 13:00
Lunch Break
Session 1
Sterile Operations
Workshop
Workshop
10:00 – 11:00
Registration
07:00 – 08:30
Registration
11:00 – 18:30
Cleaning and Disinfection –
An Advanced Workshop (Day 1)
08:30 – 17:30
Cleaning and Disinfection –
An Advanced Workshop (Day 2)
Session 2
ICH Quality Related Topics
13:00 – 16:45
Plenary Session 3
Looking into the Future
Session 3
Advanced Therapies
Regulation
Session 4
Dedicated Facilities
19:00 – 22:00
Networking Event
(including a dinner)
Additional Events of Interest
New Member Breakfast
Wednesday, 20 Feb 08
07:00 - 08:00 (for new members only)
Meeting of the PDA Interest Group
– Inspection Trends/Regulatory Affairs
Wednesday, 20 Feb 08
time will be announced (closed event)
Meeting of the Presidents of the
European Chapters
Wednesday, 20 Feb 08
17:45 - 18:45 (closed event)
Conference Agenda
Wednesday, 20 February 2008
08:30
Opening/Welcome
P lenar y S ession 1:
The European Environment
Tamás L. Paál, OGYI, Hungary
Lothar Hartmann,
F. Hoffmann - La Roche, Switzerland
Chair: Emer Cooke, EMEA
The European Union has evolved an elegant and effective set of procedures, official bodies and communications systems to effectively
conduct the business of pharmaceutical authorization and supervision. In this session, attendees will learn about how the system is
defined and organized to further the regulatory mission of the European Commission and the EMEA. They will also hear a multi-national
‘user’ experience in navigating the system. Finally, a report will be given on the status of Mutual Recognition Agreements managed by
EMEA, and the evolving role of the Qualified Person in the release of products for the European market.
08:45
Competencies Among the European Bodies –
The Role of the Various European Bodies
Sabine Atzor, EU Commission
09:30
Operating Successfully in the European Environment
Michael Doherty,
F. Hoffmann - La Roche, Switzerland
10:00
Q&A
10:15
Coffee Break
10:45
Mutual Recognition Agreements – The Impact in Practice
Katrin Nodop, EMEA
11:15
Role of the QP in Product Release for the European Market
Eija Pelkonen, NAM, Finland
11:45
Q&A
12:15
Lunch Break
P lenar y S ession 2 : Survey of New, Revised and
Pending European Guidance
Chair: Timea Molnarne Lakatost,
Vet Products Agency, Hungary
In this session attendees will be given a most current report on the GMP-related guidances which define the latest requirements for
manufacturers, distributors and importers of pharmaceuticals in Europe. This includes the GMP Guide, the various Annex’s to the Guide,
Notes for Guidances and reflection papers bearing on GMP issues. There is a lot going on in the area of GMP in Europe, and this survey
will prove it. In addition, there will be a brief industry reaction to selected GMP guidances offered for consultation in 2007.
13:15
EU Guidance Documents – Purpose, Types, Legal Relevance David Cockburn, EMEA
and New GMP Related Documents in the EU – An Overview
14:15
PDA Perspective on European Regulatory Guidance
14:30
Coffee Break
Jim Lyda, PDA Europe
Conference Agenda
Concurrent Sessions:
Parallel Sessions on Quality and GMP Topics
The balance of the afternoon will be divided into four parallel topical sessions which will allow attendees to learn in detail about specific
technical or regulatory subjects. These topics range from the PDA expertise in sterile products and operations, to the emerging European
guidance on dedicated manufacturing facilities. In addition, there are sessions covering the new ICH Q8, Q9 and Q10 and the impact
of the Advanced Therapies Regulation manufacturing and GMP.
Session 1: Sterile Operations
Chair: Véronique Davoust, Pfizer, France
15:00
Revised EU GMP Annex 1
Paul Hargreaves, MHRA, United Kingdom
15:30
Sterile Requirements Around the World
Nigel Halls, NHC, United Kingdom
16:00
Sterility – What is an Acceptable Level?
Martyn Becker, MSD, United Kingdom
16:30
Q&A
Session 2: ICH Quality Related Topics
Chair: Liam Murphy, Amgen, Ireland
15:00
Best Implementation of ICH Q10
Neil Wilkinson,
AstraZeneca, United Kingdom
15:30
Ich Q9 – Gmp Related Aspects of Emea´s Implementation Group Jacques Morénas, AFSSAPS, France
16:00
Concepts of Implementing Ich Q8 for Successful Variations
16:30
Q&A
Liz Coulson, Pfizer, United Kingdom
Session 3: Advanced Therapies Regulation
Chair: Eija Pelkonen, NAM, Finland
15:00
Revision of EU GMP Annex 2
Ian Rees, MHRA, United Kingdom
15:30
Advanced Therapy Regulation – An Overview
Paula Salmikangas, NAM, Finland
16:00
Industrial Applications of Combination Devices
Achille P. Caputi,
University Messina, Italy
16:30
Q&A
Session 4: Dedicated Facilities
Chair: Claudia Nardini, Kedrion, Italy
15:00
Dedicated Facilities – Regulatory Viewpoint
Sabine Paris, ZLG, Germany
15:30
Dedicated Facilities – Implications for Industry
Paul Wreglesworth,
AstraZeneca, United Kingdom
16:00
Case Study – Implementation of Quality Risk Management
Stephan Roenninger,
F. Hoffmann - La Roche, Switzerland
16:30
Q&A
17:00
End Day 1
19:00
Networking Event (including a dinner)
Conference Agenda
Thursday, 21 February 2008
C oncurrent S essions : Parallel Sessions on Quality and GMP Topics
The second day of the conference will be divided into four new and extended parallel topical sessions which will allow attendees to learn
in detail about specific technical or regulatory subjects. These topics include the relationship between GMP of regulatory quality; the
latest developments surrounding starting materials, active substances, excipients and atypical actives; GMP inspections and Investigational
Medicinal Products (IMPs).
Session 5: Regulatory Quality
Chair: Tesh Patel,
Abbott Laboratories, United Kingdom
08:30
Variation Regulation, Certificate of Suitability (CEP) and
Registration Procedures in the EU (National, MRP, DCP,
Centralised)
Barbara Jentges,
PhACT GmbH, Switzerland
09:15
Changes Foreseen in the Variations Regulation
in a Future Revision
Peter Bachmann, BfArM, Germany
09:45
How to Achieve and Ensure Regulatory Compliance
Monica Unger-Bady,
Bayer Schering Pharma AG, Germany
10:15
Coffee Break
10:30
Dealing with GMP Non-Compliance
David Cockburn, EMEA
11:00
Aligning the QP Role to a Modern Pharmaceutical Industry
John O’Sullivan, Pfizer, Ireland
11:30
Q&A
Session 6: Starting Materials
Chair: Jacques Morénas,
AFSSAPS, France
08:30
Starting Materials Regulation and Requirements for Excipients
Sabine Atzor, EU Commission
09:00
Level Playing Field of APIs
Chris Oldenhof, DSM, The Netherlands
09:30
Which GMP Standard Should be Applied for Excipients?
Janeen Skutnik, Pfizer, Belgium
10:00
Coffee Break
10:15
Raw Materials (API Starting Materials) for APIs
Lionel Vionery, AFSSAPS, France
10:40
Starting Materials (APIs, Excipients) for Medicinal Products
Miguel Sanchez, AFSSAPS, France
11:00
Atypical Actives – Which Standard Should be Applied?
Brian Matthews, Alcon, United Kingdom
11:30
Q&A
Headline Agenda
Conference
Session 7: GMP Inspections
Chair: David Cockburn, EMEA
08:30
Inspections by EU Authorities
Simona Raicu, ANM, Romania
09:00
How Does Europe Ensure Consistent Interpretation of Gmp
Regulations Among the Various Inspectorates?
Emer Cooke, EMEA
09:30
Inspections Update: Major Observations
Tor Gråberg, MPA, Sweden
10:00
Coffee Break
10:30
Inspectors‘ Expectations
Paul Hargreaves,
MHRA, United Kingdom
11:00
Industry Perspective of Inspections
John Kerridge, Eli Lilly and Company Ltd.,
United Kingdom
11:30
Q&A
Session 8: Investigational Medicinal Products (Imps)
Chair: Thomas Linz, Bayer Schering
Pharma AG, Germany
08:30
GMP for IMPs (2003/94)
Chris Cullen, IMB, Ireland
09:00
Requirements for APIs During Phase I - III
Morten Munk,
CMC Biopharmaceuticals, Denmark
09:30
Labeling and Release Management During Imp Distribution
in the EU
Michael Djie,
F. Hoffmann - La Roche, Switzerland
10:00
Coffee Break
10:30
Challenges Arising from Conducting Clinical Trials in Europe
Hanif Patel, GSK, United Kingdom
11:00
Requirements for Medicinal (Drug) Products
Karen Ginsbury,
Pharmaceutical Consulting Israel Ltd., Israel
11:30
Q&A
12:00
Lunch Break
Conference Agenda
P lenar y session 3 :
Looking into the Future
Chair: Tim Marten,
AstraZeneca, United Kingdom
The closing plenary session of the conference will take a look into the pharma ‘crystal ball’. The session will open with a top level view
of the pharmaceutical sector in Europe, it’s regulatory oversight, and the how both benefit and serve the citizens, the business and, most
importantly, the patient. This will be followed by a presentation on the ‘ICH Quality Strategy and Vision’ by one of the best known leaders
in the European quality regulation scheme. Finally, we will hear industry and regulatory views about the future direction and focus of the
European Inspection program, and what it may look like in coming years.
13:00
The Expectations of the Society Towards
the Pharmaceutical Business
Representative
of European Commision (invited)
13:30
ICH Quality Strategy and Vision
Jean-Louis Robert,
Ministère de la Santé, Luxembourg
14:00
Coffee Break
14:30
Future Inspections and Assessment – Industry Expectations
15:00
Future Inspections and Assessment – Regulatory Discussions Regulatory Speaker from EMEA (invited)
15:30
Panel Discussion:
Harmonisation and Communication Efforts
– Is Europe on the Right Track?
16:30
Closing Remarks
16:45
End of Conference
Tim Marten, AstraZeneca, United Kingdom
Emer Cooke, EMEA
Georg Roessling, PDA Europe
Headline
PDA
TRI Training Courses
Preceeding the 2008 PDA/EMEA Joint Conference, the PDA Training and Research Institute (PDA TRI) is offering six
training courses geared toward your professional and career development. Course topics include Drug Registration
in Europe, ICH Q10 and its Impact on the Pharmaceutical Industry, and Quality System Strategies for Investigational
Drugs. Please visit the Conference site for additional course listings.
ICH Q10 and its Potential Impact on the Pharmaceutical Industry – NEW COURSE! 09:00 – 16:30
18 February 2008 PDA #172
Marco Budini, QA Director, Novartis (retired)
This training course focuses on the content and comments of the ICH Draft Q10 Guideline. The course will evaluate
whether or not the document can be turned into practical solutions for the pharmaceutical industry. The training
will provide in-depth information regarding global regulatory expectations for the design, management and
inspection of modern quality systems expressed in this document. Focus will be on the challenges faced by virtual,
small and large companies in developing and implementing robust quality systems compliant with this Draft
Guideline. Application to drug substance and drug product – including biotechnology facilities – will be discussed.
Drug Registration in Europe – An Insightful View – NEW COURSE! 09:00 – 16:30
18 February 2008 PDA #104
Barbara Jentges, Managing Director, PhACT GmbH
This course will provide participants with an overview of the European Registration Procedures. Particularly, the
course will focus on regulatory milestones during drug development (clinical trial application, marketing authorization application), registration procedures and application types, alternative ways to submit quality data for
drug substance (Certification of Suitability and Active Substance Master File), and post-authorization surveillance
(handling variations, applying for an extension, renewal application, pharmacovigilance).
Preparing for and Passing a European or United States GMP Inspection 09:00 – 16:30
18-19 February 2008 PDA #263
Michael H. Anisfeld, Globepharm Consulting
GMP inspectorates from EU nations (EMEA) and from the United States (FDA) have developed tough inspection
programs to assure GMP compliance in operations and laboratory testing. This course is designed to provide background and insight into the inspection processes of the EMEA and FDA, and to provide practical strategies and
tactics that a company must know and implement in order to have the potential to pass an inspection the first time
through. EMEA and FDA inspections have many similarities but also substantial differences. Companies need to
be intimately familiar with these differences and how they impact the handling of an inspection. The course will
touch on everything, and we do mean everything, you need to know to have a smooth and successful inspection.
Quality System Strategies for Investigational Drugs
09:00 – 16:30
18-19 February 2008 PDA #149
Karen Ginsbury, President, Pharmaceutical Consulting Israel Ltd.
This two-day course will address the FDA draft Guidance for the manufacture of drugs for Phase I trials and
compare its recommendations with Annex 13 of the EU GMPs. It will equip attendees with tactics for addressing
“how much” quality is necessary at each stage of the development process and how to introduce quality without
antagonizing the Chief Scientific Officer and without paralyzing the system or impeding creativity. Development
of a methodical, ordered but efficient and flexible system will ensure safety while allowing the company to move
forward fast. The course is designed to be highly interactive with the opportunity for the audience to ask questions
and to exchange views with other participants struggling with similar conundrums.
10
PDA TRI Training Courses
Risk-Based Approach and Risk Management in Pharmaceutical Manufacturing Processes
09:00 – 16:30
19 February 2008 PDA #133
Trevor Deeks, Director of Development, Product Development - UK, Emergent BioSolutions
The FDA is keen to encourage companies to adopt risk management techniques in their manufacturing operations. The initiative GMP in the 21st Century – A Risk-Based Approach advocates the use of these techniques. This
course will provide participants with a regulatory and historical background to pharmaceutical risk assessment and the use of risk assessment and risk management tools. It will be comprised of a combination of formal
presentations, group exercises and group discussion sessions. Group exercises will allow attendees to learn about
risk assessment tools by using them to solve hypothetical problems based on real life experiences of the course
tutor. Following the risk assessment exercise, each group will be asked to develop a control philosophy to manage
the risks identified.
Briefing Meetings, Scientific Advice / Protocol Assistance, Pre-Submission Meetings
with EMEA - When to Do What and How to Prepare – NEW COURSE! 09:00 – 16:30
19 February 2008 PDA #173
Barbara Jentges, Managing Director, PhACT GmbH
This course will provide participants with an insight into the different forms of pre-submission meetings with the
EMEA prior to the submission of a marketing authorization application within the centralized procedure. How
and when to apply for what kind of meeting, as well as how to prepare for it will be the basis of much discussion.
Scientific Advice and Protocol Assistance meetings will also be topics of focus, and participants will be able to
discuss the concepts as well as differences between the two.
For more information on PDA TRI training courses please contact Gail Sherman at sherman@pda.org
Registration Fees for PDA TRI Training Courses
One-day Training Course
PDA Member € 995
Nonmember* € 1395
Government/ Health Authority € 400
Academic ** € 400
*Registration fee includes a one-year PDA membership.
**Must be a PDA Member to receive this rate.
Two-day Training Courses
PDA Member € 1595
Nonmember* € 1995
Government/ Health Authority € 650
Academic ** € 650
11
Headline
PDA
Workshop on Cleaning and Disinfection
Cleaning and Disinfection – An Advanced Workshop
18-19 February 2008
Learn how to control contamination within your classified environments with a successful cleaning and disinfection program. Attendees will discuss and learn how to choose and apply cleaners and disinfectants properly depending on the
surface, environment and product, which will reduce labour costs and commodity usage. The wide range of lectures
include sanitization of a Class 100/10,000 pharmaceutical cleanroom and other classified environment when performing
aseptic processes, proper equipment cleaning/disinfection procedures, and validation of disinfectant performance and
application. In the end, participants will gain a profound understanding that will allow them to develop validation protocols
and a proper cleaning and disinfection program to suit their professional and business needs.
DAY 1
10:00 – 11:00 Registration
11:00 – 11:45 Basics Overview
Cleaning Chemistry and Cleaning Physics
Cleaning Targets
Designing an Effective Cleaning Cycle
Dusko Filipovic, Partikel-Messtechnik AG
08:30 – 09:15 Directives and Guidelines in Relation to the
Different Types of Contamination in an APA
Peter Koger, Veltek
09:15 – 10:00 Environmental Monitoring, Viables
Stephen Trombetta, Veltek
10:00 – 10:30 Coffee Break
11:45 – 12:30 Basics Overview (cont.)
Regulatory Requirements
Documentation Issues
Sampling Techniques and Analytical
Methods/Residues and Limits
Esmaeil Ektefaie, Baxter BioScience
10:30 – 11:15 Environmental Monitoring, Non-Viables
Joerg Dressler, PMT
12:30 – 13:30 Lunch Break
12:30 – 13:30 Lunch Break
13:30 – 14:30 CIP-Technology
Stephen Trombetta, Veltek
13:30 – 14:30 Smoke Studies, Air Made Visible
John Lindsay, Aseptic Solutions
14:30 – 15:30 Coffee Break
14:30 – 15:30 People in an APA
Peter Koger, Veltek
11:15 – 12:30 Aseptic Manufacturing,
the Strands of the Rope
John Lindsay, Aseptic Solutions
15:30 – 16:00 Spray Applications
Kent Milton, Alfa-Laval
15:30 – 16:00 Coffee Break
16:00 – 17:30 Derouging and Passivation
Florian Andre, Henkel Beiz- und
Elektropoliertechnik GmbH & Co. KG
16:00 – 17:00 Ask the Inspector/Ask the Consultant
Chair: Volker Eck, PDA Europe
Bernd Boedecker, T&IIA 1 (Inspector)
Herbert Syrowatka, QSC 2 (Consultant)
17:30 – 18:30 Ask the Inspector/Ask the Consultant
Chair: Volker Eck, PDA Europe
Bernd Boedecker, T&IIA 1 (Inspector)
Herbert Syrowatka, QSC 2 (Consultant)
Benefits of Attendance
• Reduce labour costs and disinfectant usage
• Select and validate appropriate cleaners, disinfectants
and sporicides to meet your specific operational
requirements
• Develop proper procedures to ensure safety of cleaning personnel
• Learn proper disinfectant rotation to reduce facility
and equipment surface deterioration or rouging
• Learn best practices in derouging surfaces of your
equipment
*Registration fee includes a one-year PDA Membership. **Must be a PDA Member to receive this rate.
12
DAY 2
Trade & Industrial Inspection Agency
Quality Systems Consulting GmbH
1
2
• Decrease levels of viable and non-viable contaminants
in your facility to lessen product contamination risk
• Ensure your cleaning and disinfection program
complies with current regulatory guidelines
• Make your current maintenance program more
efficient and cost-effective
• Ask experts in the field your most urgent questions
during dedicated Q&A sessions
Registration Fee for Workshop
PDA Member € 1095
Nonmember* € 1290
Government/ Health Authority € 455
Academic ** € 455
General Information
Registration Hours
Pre-Registration
Sunday, 17 Feb 2008
16:00 – 20:00
PDA TRI Training Courses
Monday, 18 Feb 2008
08:00 – 09:00
Tuesday, 19 Feb 2008
08:00 – 09:00
PDA Workshop
Monday, 18 Feb 2008
10:00 – 11:00
Tuesday, 19 Feb 2008
07:00 – 08:30
Conference/Exhibition
Wednesday, 20 Feb 2008
07:00 – 08:30
Thursday, 21 Feb 2008
07:00 – 08:30
Venue and Hotel
Travel to Budapest
Novotel Budapest Congress & World Trade Center
Alkotás utca 63-67
H-1123 Budapest
Tel: +36-1-372-5700
Fax: +36-1-466-5636
Email: bcwtc@accor.com
www.bcwtc.hu
Air – Budapest is an easy flight from major European
and US cities. It is served by two airports, called
Ferihegy 1 and Ferihegy 2 which are 23 kilometers
(30+ minutes) from the Novotel by taxi or shuttle bus.
www.bud.hu/english
Reservations
PDA has secured a limited number of rooms at a special group rate until 17 December 2007. Please inform
the reservation department that you are attending the
2008 PDA/EMEA Joint Conference in order to benefit
from this agreement.
To make your reservation over the phone, please dial
+36-1-372-5700 or visit www.pda.org/emea2008 to download the hotel reservation form and fax it back to
+36-1-466-5636.
Single room: € 99*
Double room: € 115*
* Rates per room and night, breakfast and 20% VAT
included. The rate does not include local tax, which is
3% of the room price.
Housing at the selected hotel will be in high demand, so
we strongly recommend making your reservations early.
Train – Budapest has direct rail links to 25 capitals with
more than 50 international connections each day. The
Novotel is a short distance from the Western Railway
Station Budapest.
Currency 1 € = approx. 252 HUF (Hungarian Forint)
1 US$ = approx. 174 HUF
(exchange rate per 3th of November 2007)
Networking Event
A Gala Dinner will take place at a typical Hungarian
restaurant, which offers a wonderful view of the
Danube. Decorated with rustic-style wooden chairs
and tables, it looks and feels like a traditional Hungarian restaurant. They serve up classic favorites and they
have also a good selection of typical and famous
Hungarian wines. Wednesday, 20 February 19:00 - 22:00
Special Requirements
If you require special accommodations to fully participate, please attach a written description of your needs
with your registration form. Specific questions can be
directed to info-europe@pda.org.
13
Headline & Sponsorship Opportunities
Exhibition
The 2008 PDA/EMEA Joint Conference is a great opportunity for your company to gain onsite exposure in front of highly-qualified, upper-level professionals in the pharmaceutical and
biopharmaceutical industry.
Exhibit at this event and let your company‘s products or services become a valuable tool or
resource for our attendees.
Sponsorship opportunities, which will accentuate your company’s brand name to all conference
attendees, are available at this conference. As a sponsor you will receive recognition on PDA’s
website, at the opening session, in the exhibit guide and on signs throughout the exhibit hall.
For more information,
visit www.pda.org/emea2008 or contact:
Astrid Guenther,
Marketing Manager, PDA Europe
Tel: +49 (0) 33056-237711
Email: guenther@pda.org
Cindy Tabb
Senior Manager, Membership and Sales, PDA
Tel: +1 (301) 656-5900 ext. 222
Email: tabb@pda.org
Nahid Kiani
Vice President, Membership Services and Sales, PDA
Tel: +1 (301) 656-5900 ext. 128
Email: kiani@pda.org
14
2008 PDA / EMEA Joint Conference
Registration
Form
Conference: 20-21 February 2008, Budapest, Hungary
Training Courses, Workshop: 18-19 February 2008
3 Ways to register FAX: +49 33056 23 77 77 online: www.pda.org/emea2008
MAIL: PDA Europe, Adalbertstr. 9, 16548 Glienicke/Berlin, Germany
1
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(C h e c k o n l y i f y o u a r e s u b s t i t u t i n g f o r a p r e v i o u s l y e n r o l l e d c o l l e a g u e; a n o n m e m b e r s u b s t i t u t i n g f o r a m e m b e r m u s t p a y t h e m e m b e r s h i p f e e.)
2
Conference Registration
By 14 Dec 2007
PDA Member
Nonmember*
Government/Academic**
3
All Prices in Euro
1695
1890
765
(
(
(
After 14 Dec 2007
1895
2090
850
(
(
(
Would you like to have the Delegate Binder on: ( paper or ( memory stick.
If you don‘t make a choice, you will get a memory Stick. If you like to have
both, we will charge you 30 Euro.
* Nonmember registration fee includes a one-year PDA membership. If you do not wish to join PDA and receive the benefits
of membership, please check here (same rate applies). (
** Must be a PDA academic member to receive this rate.
Course Registration
PDA Member
Training Course
995
PDA #172: ICH Q10 and its potential impact on the Pharmaceutical Industry – NEW COURSE! (18 Feb) (
(
995
PDA #104: Drug Registration in Europe – An Insightful View – NEW COURSE! (18 Feb)
(
1595
PDA #263: Preparing for and Passing a European or United States GMP Inspection (18-19 Feb)
(
1595
PDA #149: Quality System Strategies for Investigational Drugs (18-19 Feb)
995
PDA #133: Risk-Based Approach and Risk Management in Pharmaceutical Manufacturing Processes (19 Feb)(
995
PDA #173: Briefing Meetings, Scientific Advice / Protocol Assistance, Pre-Submission Meetings with (
EMEA - When to Do What and How to Prepare – NEW COURSE! (19 Feb)
(
1095
Workshop: Cleaning and Disinfection – An Advanced Workshop (18-19 Feb)
Nonmember*
Gov./Health Auth.
Academic**
(
(
(
(
(
(
1395
1395
1995
1995
1395
1395
(
(
(
(
(
(
400
400
650
650
400
400
(
(
(
(
(
(
400
400
650
650
400
400
(
1290
(
455
(
455
Special Dietary Requirements (please be specific)
4
Payment Options
Invoice ( Please mark here to request an invoice from PDA. You are not considered registered for a PDA event until payment
is received and a confirmation letter is issued by PDA. Should you attend an event without a formal confirmation or receipt of
payment you will be required to provide a credit card as guarantee of payment.
By Bank Transfer
By Credit Card
Beneficiary: PDA Europe gGmbH
Account No: 09 228 735 00
IBAN: DE73 1007 0024 0922 8735 00
BIC (SWIFT-Code): DEUTDEDBBER
Bank Address: Deutsche Bank , Welfenallee 3-7, D-13465 Berlin, Germany
PDA Europe VAT I.D.: DE254459362
Please bill my:
(required if paying in foreign currency; prevailing exchange rate at date of submission will apply)
*All cards are charged in Euro.
(American Express, MasterCard, VISA) clearly indicating account number and expiration date.
(American Express
(MasterCard (VISA*
Total Amount
Card Number
Exp. Date
Name (exactly as it appears on card)
Signature
CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt
of confirmation letter. If you have submitted a purchase order or have received an invoice please be advised that you are not a confirmed registrant. You are not confirmed until payment has been received.
Please submit payment for the prevailing rate. SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. If you are a non-member
substituting for a member, you will be required to pay the difference of the non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form. REFUNDS: Refund
requests must be in writing and faxed to PDA at +49 (33056) 23 77 77 (emails are not accepted). If your written request is received on or before 18 January 2008, you will receive a full refund
minus a € 150 handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee at
the on-site registration rate if your cancellation has not been received in writing on or before 25 January 2008. On-site registrants are not guaranteed to receive conference materials until all advanced
registered attendees receive them. Refund for Courses: If your written request is received by 28 January 2008, you will receive a full refund less a € 150 processing fee. After that time, no refund
or credit requests will be approved. EVENT CANCELLATION: PDA reserves the right to modify the material or speakers/instructors without notice, or to cancel an event. If an event must be canceled,
registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact
PDA at info-europe@pda.org or fax to +49 (33056) 23 77 77.
PDA USE ONLY
Date:
Check:
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Account:
HeadlinePDA Europe Conference & Event Calendar
2007/2008
2007
2008
The Universe of Pre-filled Syringes and Injection Devices
Conference/Exhibition: 27 - 28 November – Berlin, Germany
Training Courses: 29 - 30 November
Contact: info-europe@pda.org
Investigational Medicinal Products:
How to Get the GCP/GMP Interface Right
Conference/Exhibition: 23 - 24 January – Paris, France
Training Course: 22 January
Contact: Volker Eck, eck@pda.org
PDA/FDA Co-Sponsered Conferences Series
on Quality Systems
Conference: 10 - 11 December – Dublin, Ireland
Contact: Wanda Neal, neal@pda.org
2008 PDA/EMEA Joint Conference
European GMP: Current Issues and Future Developments
Conference/Exhibition: 20 - 21 February – Budapest, Hungary
Training Courses: 18 - 19 February,
Contact: info-europe@pda.org
PDA Workshop on Cleaning and Disinfection
Workshop: 18 - 19 February
Contact: info-europe@pda.org
PDA Compendial Conference in cooperation with
Ph.Eur., JP and USP
Conference/Exhibition: 1 - 2 April – Frankfurt, Germany
Contact: info-europe@pda.org
PDA Virus Safety Forum 2008
Conference/Exhibition: 3 - 4 June – Berlin, Germany
Contact: info-europe@pda.org
TSE Symposium 2008
5 - 6 June – Berlin, Germany
Contact: info-europe@pda.org
2008 PDA/EBE
Biopharmaceutical Development and Manufacturing
Conference/Exhibition: 24 - 25 June – Dublin, Ireland
Contact: info-europe@pda.org
2008 Pharmaceutical Freeze Drying Technology
Conference/Exhibition: 23 - 24 September – Brussels, Belgium
Training Course: 25 September
Contact: info-europe@pda.org
2008 PDA Visual Inspection Forum
Conference/Exhibition: 14 - 15 October – Berlin, Germany
Training Courses: 16 - 17 October
Contact: info-europe@pda.org
For latest info: www.pda.org/europe
Subjects to change
Pharmaceutical Cold Chain Management
Conference/Exhibition: 4 - 5 November – Berlin, Germany
Training Courses: 6 - 7 November
Contact: info-europe@pda.org