European Microbiology Conference

+ Workshop

This conference is recognised for the ECA GMP Certification Programme „Certified Microbiological Laboratory Manager“. Please find details at www.gmp-certification.eu

25-26 April 2018, Vienna

SpeakersWalid El Azab Steris Corporation, Belgium

Dr Isabelle Bekeredjian-Ding Paul-Ehrlich Institut, Germany

Dr Elena Bolchakova Thermo Fisher Scientific , USA

Dr Marja Claassen-Willemse MSD, The Netherlands

Sinéad Cowman Lonza, UK

Dr Sven M. Deutschmann Roche, Germany

Carolin FrommLabor L+S, Germany

Rob van Gammeren Vivenics, The Netherlands

Dr Marcel Goverde MGP, Switzerland

Dr Jeanne Grosselin bioMérieux, France

Pieta C. IJzerman-Boon MSD, The Netherlands

Prof. Edwin van den HeuvelUniversity Eindhoven, The Netherlands

Dr Gerald Kindermann F. Hoffmann-La Roche, Switzerland

Scott Kaszuba Pfizer, USA

Di MorrisGSK, United Kingdom

Dr Antje MotzekLabor L+S, Germany

Dr Youwen Pan Genentech, USA

Dr Petra Parizek Laves Arzneimittel, Switzerland

Mousumi Paul MSD, USA

Highlights � Data Integrity – focused on Microbiology Laboratory Challenges

� ECA Guidance for Microbiological Environmental Deviations in Non-Sterile Manufacturing

� Next Generation Sequencing

� Case Studies: Validation of different Microbiological Methods

Data Integrity in Microbiology | 24 April 2018

Invitation to the European Microbiology Conference 2018 with pre-conference workshop

Introduction

European Microbiology Conference | 25-26 April

Objectives

This event offers you a unique possibility to become acquainted with ongoing regulatory requirements, the development of microbiological methods for quality and process control as well as with the recent experiences in microbial contamination control.

Speakers from different scopes of pharmaceutical microbiology will give you the chance to get to know the different views on versatile microbiological topics. Also, as a participant you will have ample opportunity to discuss your specific issues with speakers and other participants.

Interdisciplinary lectures will give you an additional benefit for under-standing the current developments in pharmaceutical QC.

Background

The role of pharmaceutical microbiology is getting more and more important. It is also increasingly in the focus of regulators during pro-duct submission and inspections. Current challenges are Low Endo-toxin Recovery, implementation of alternative microbiological methods and the ongoing issues with contamination control – there was an increasing number of findings in the authority reports.

The challenge is therefore to satisfy regulatory requirements alongside management’s financial expectations.

Target Audience

This conference is of interest to professionals in microbiology from � Pharmaceuticals and Biopharmaceutical Companies � Academic Research Institutions � Government Agencies � Contract Service Laboratories

who are involved in � Contamination Control � Monitoring � Product Testing � Validation � Quality Affairs � Regulatory Affairs � Research and Development

Moderator

Dr Marcel Goverde, MGP Vice Chair of ECA’s Pharmaceutical Microbiology Working Group

Dear Colleague,

I would like to invite you to the European Microbiology Conference (EMC) and the Workshop on Data Integrity in Microbio-logical Laboratories, organised by the ECA Academy in Vienna, Austria.

The ECA has been organizing the European Microbiology Conference every spring for ten years. The very good responses from attendants, speakers and exhibitors alike turned it to an annual event with presentations and workshops on current topics in pharmaceutical microbio-logy. In 2018, the EMC will be combined with a Pre-Conference Workshop on Data Integrity, a topic which challenges all parts of pharmaceutical quality management. The workshop will focus on the requirements and approaches to handle it in the field of microbiology.

The combination of these two events gives you an outstanding possibility to keep you up-to-date with the current developments and state-of-the-art handling in microbiological quality control. Pharmacopoeial experts, representatives from pharmaceutical quality control and from testing laboratories will show you their experiences, what their challenges are and how they implemented an adequate microbiological quality control in their companies.

The pharmaceutical microbiologist plays a key role in all aspects of development, manufacture and control of medicinal products and their com-ponents. It is thus the aim of this conference and workshop to equip the pharmaceutical microbiologist with practical and applicable knowledge and “know-how”. In addition, it will provide a forum for interesting and open discussions between presenters, regulators and your colleagues from the industry.

It would be a great pleasure for me if you joined us in Vienna.

Dr Sven M. DeutschmannChairman of ECA’s Pharmaceutical Microbiology Working Group

Automation in the QC Microbiology Lab: Implementation of the Charles River Nexus™ testing systemScott Kaszuba, Pfizer

� Evaluating the Nexus system � Validation points to consider � Data Integrity related to the Nexus system

ECA Guidance for Microbiological Environ-mental Deviations in Non-Sterile ManufacturingMarcel Goverde, MGPDavid Roesti, Novartis

� Differentiation between critical and non-critical deviations

� Clear definition of actions to be taken � Needs for final approval by QA � Propositions for control levels

Q&A on Microbiological Media ChallengesJeanne Grosselin, bioMérieux

� Evaluation of the recovery discrepancies of different microorganisms using contact plates

� Performance evaluation of the recovery of microor-ganisms with contact plates application

� Influence of different types of surfaces and different contact plates suppliers on microorganisms recovery

Validation of an Alternative Microbial Enumeration AssaySven Deutschmann, Roche

� Introduction � Requirements � Method Validation

Validation of Microbiological IPC MethodsPetra Parizek, Laves

� IPC of biofermentation samples � Practical examples of validation approaches

The unavoidable need for automation in microbiological QC of biomedicinesIsabelle Bekeredjian-Ding, Paul-Ehrlich Institut

� Current technical possibilities for automation of microbiological methods

� Pros and cons of the available techniques � How automation contributes to standardization of

microbiological QC � How these methods can improve microbiological QC

of biomedicines

How to handle Spreader BacteriaMarcel Goverde, MGP

� What is the spreading phenomenon? � How many CFUs are needed to spread? � How can spreaders be inhibited?

Unique global collaboration through BPOG and Microbial control VisionMousumi Paul, MSD

� Mission, Benefits of membership with BPOG

� 6 Phorums covering all aspects of biopharma operations

� Microbial control Workstream efforts � Vision and Five Year Plan for implementation

Common failure observed during autoclave and sterilization validation and routine monitoring – case studiesWalid El Azab, Steris Corporation

� Discuss the top microbiological considerations when validating, requalifying and routine use of steam sterilization.

� Impact of the different regulatory updates (EMA and future Annex 1 guidance) from an end-user perspective.

� Common mistakes and lessons learned regarding steam sterilization autoclaves including Steam in Place (SIP) systems using case studies

MuScan as a direct detection method of bioburden in column rinse samplesMarja Claassen-Willemse, MSDPieta C. IJzerman-Boon, MSD

� Comparability of MuScan with compendial method � Analysis of non-CFU counts in water matrix

Next generation sequencing (NGS) and microbiological quality controlElena Bolchakova, Thermo Fisher Scientific

� Viral detection with massive parallel sequencing of the amplified viral genomic tags

� Benefits of MPS or NGS � Possible Challenges like host cell background � Current conclusions

Programme

Social Event | 25 April

On 25 April, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

Programme

Rapid Micro Methods Development and Global Deployment approach at MerckMousumi Paul, MSD

� Vision and Strategy for Global Deployment of RMMs at Merck

� Business Case development to facilitate adoption � Phases from development of Technology to imple-

mentation of RMMs in routine � Overcoming challenges associated with the

Implementation of Rapid Micro Methods � Case studies/examples

Modern Micro Methods and their LODEdwin van den Heuvel, University of Eindhoven

� Probabillity of Detecting Contaminations � The USP Approach – Risk Based or not � Relationship of LOD and Sampling Plan � How to handle it in Practice

Different matrices require different solutionsCarolin Fromm, Labor L + S

� Different Matrices � Selection of the best fit rapid method for sterility test � Pros and cons

Workshop: Data Integrity in Microbiology | 24 April

Objectives

This workshop will cover the regulatory requirements and present approaches and practical experiences on the implementation of data integrity strategies in microbiological laboratories. It will provide you the possibility to discuss the challenges of the ongoing automation of methods and processes in relation to the increasing requirements of data integrity.

Background

Even Data Integrity is one of the basic GMP principles. Multiple Data Integrity issues were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections.

As a consequence, international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.

Even though the guidelines are not intended to impose additional regulatory burden upon the regulated companies, a lot of uncertainty predominates the pharmaceutical industry about how to implement these requirements into the daily business.

Microbiological laboratories are influenced by these developments, as well.

Target Audience

All persons which will be involved in collecting, analysing and trending data in microbiological laboratories and will be challenged by the lab data integrity requirements. Additionally, all persons from QC and QA who have to judge these data for risk evaluation or release questions.

Moderator

Dr Sven M. Deutschmann, Roche Diagnostics GmbHChairman of ECAs Pharmaceutical Microbiology Working Group

Presentations

Requirements on Data Integrity in LaboratoryGerald Kindermann, F. Hoffmann-La Roche, Switzerland

Life cycle approach for qualification of computerized systems in microbiological testingDr. Antje Motzek, Labor L+S AG, Germany

� Critical data integrity aspects in CS lifecycle � Types of questions for qualification of CS � Practical examples for documentation

Data Integrity – Challenges in MicrobiologyDi Morris, GSK, United Kingdom

Importance of Data Integrity when Testing for EndotoxinSinéad Cowman, Lonza, UK

Data Integrity Assessment and Remediation of Computerized QC Lab Equipment in PharmaRob van Gammeren, Vivenics, The Netherlands

� Requirements and approach � Experiences and challenges � Recommendations

Implementation of contemporaneous verification for visual readouts in QC microbiological tests using a risk based approachYouwen Pan, Genentech, USA

� Characteristics of non-automatic QC microbiological tests in terms of data integrity (DI)

� Utilization of risk assessment to identify the microbial tests requiring contemporaneous verification

� Risk mitigation strategy on DI of microbiological tests

Speakers

Speakers Conference & Workshop

Walid El Azab, Steris Corporation, Belgium Walid is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. He currently provides technical support related to cleaning chemistries, disinfect-ants and sterility assurance products and their application and validation. His areas of expertise include both upstream and downstream biopharmaceutical operation and validation. Walid has held various positions including Project Manager, Inspection Readiness Manager, Quality and Regula-tory Manager, and Qualified Person (QP). Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liege, Belgium and is green belt certified.

Dr Isabelle Bekeredjian-Ding, Paul-Ehrlich Institut, German Federal Agency for Vaccines and Biomedicines Isabelle Bekeredjian-Ding is head of the Division of Microbiology at Paul-Ehrlich-Institut (PEI) and associate professor at the University of Bonn. Before she joined PEI she was deputy director of the Institute for Medical Microbiology, Immunology and Parasitology at the University Hospital in Bonn. After medical school and a PhD equivalent in Heidelberg, Germany, she received clinical training in Munich and the medical microbiology training in Heidelberg. Her research background includes two postdoctoral fellowships in Dallas, TX and in Munich, Germany. Dr. Bekeredjian-Ding is member of the advisory board of the ECA Foundation Pharmaceutical Microbiology Working Group. Dr Elena Bolchakova, Sr.Staff Scientist, Themo Fisher Scientific, USADr Elena Bolchakova graduated from the Biology depart-ment of Moscow State University in Russia and received her PhD degree from the Institute of Molecular Genetics in Mos-cow. After moving to the United States, she joined Applied Biosystems as a postdoctoral fellow and then became a re-search scientist. During her tenure with Applied Biosystems/Life Technologies/Thermo Fisher Scientific Dr Bolchakova led development of several new commercial products in the area of Sanger sequencing, qPCR detection of microbial pathogens and biological contaminants in pharmaceutical products, MicroSEQ® ID microbial identification system and 16S Metagenomic analysis of microbial communities using massively parallel sequencing. Dr Bolchakova is currently working on a new rapid detection method of viral contami-nation in cell cultures based on NGS of PCR-amplified viral genomic signatures.

Dr Marja Claassen-Willemse, MSD Oss, The Netherlands Maria Claassen studied Biology at the Radboud university of Nijmegen and got her PhD on Virology at the Utrecht University. After a post doc position in the field of Immu-nology at the Erasmus MC in Rotterdam, she joined MSD where she had varying positions in development, QC and manufacturing. Currently she is Senior Specialist of the Global Center of Expertise Microbiology, The Netherlands,

involved in rapid microbiological method deployment in the QC laboratories of MSD.

Sinéad Cowman, EU Business Development Manager - Informatics, Lonza, UK Sinéad studied Microbiology at Trinity College Dublin and has over 15 years’ experience in QC Microbiology. She joined Lonza in 2005 to manage their endotoxin business in Ireland and for the past 7 years has been involved in their informatics division. She has worked with many organizations from small biotech to global pharmaceutical companies to implement and validate a paperless solution for QC Microbiology and help them achieve an automated integrated approach to data collection and evaluation.Currently studying Strategy and Innovation at Oxford University she is focused on driving the strategic direction of informatics at Lonza.

Dr Sven M. Deutschmann, Roche Diagnostics GmbH, Penzberg, GermanyIn 1995 Sven Deutschmann joined Roche Diagnostics GmbH. Dr Sven M. Deutschmann studied at the University of Brunswick. He holds a PhD (1994) and a MSc/Diplom (1991) in Biology. In 1995 he joined Roche Diagnostics GmbH. In the past two decades he took over increasing responsibilities within the local and global Roche QC Net-work. He has been extensively involved in various fields of Quality Control - Microbiology, Bioassay, Adventitious Agents Testing, Environmental Monitoring, Cleaning Analytics/Validation, and many more. Currently, Sven is Head of a Corporate Function within the Global QC Net-work of Roche called “Analytical Science and Technology – Adventitious Agents Testing & Alternative Micro-biological Methods”.

Carolin Fromm, Labor L+S AG, Bad Bocklet, GermanyCarolin Fromm studied Bioanalytics (Master) at the Univer-sity of Applied Science Coburg. Since 2015 she is head of department research and development at Labor L+S AG. Her responsibility includes the project “Implementation and validation of a rapid sterility test” as well as the imple-mentation of new customized microbiological methods.

Rob van Gammeren, Project Manager Data Integrity, Vivenics, The NetherlandsRob studied Chemistry (Master) at the Radboud University Nijmegen in the Netherlands. He has extensive ICT project management experience. After working for Akzo Nobel since 1989, he joined Organon (nowadays MSD) in 2002 where he was involved in the development of data man-agement and visualization software (‘decision support tools’) for pharmaceutical research. Rob joined Vivenics, an Informatics Consultancy firm, early 2016 to manage data integrity compliance projects within the pharmaceu-tical industry.

Speakers

Dr Marcel Goverde, MGP Consulting, SwitzerlandMarcel Goverde earned his PhD in ecology at the Univer-sity of Basel where he subsequently was employed as an aca-demic tutor. 2002 to 2010 he was leading the quality control lab for non-sterile products as well as the lab for research & development of microbiological methods at F. Hoffmann-La Roche Ltd in Basel. After one year at Novartis ChemOps Ltd. running the microbial QC lab for API and drug development, he started his own company for con-sulting and training. Furthermore he is the Swiss delegate for group 1 (microbiological and statistical methods) and vice-chair of the ECA Pharmaceutical Microbiology Working Group.

Dr Jeanne Grosselin, bioMérieux, FranceDr Jeanne Grosselin graduated as engineer from a French scientific school (INSA, Lyon) and received her PhD degree from University of Paris Sud 11 in France. In 2013 she started her carrier at bioMérieux as R[&]D senior scientist. She worked for 3 years on a rapid alternative microbiological method based on a solid cytometry technology. She is currently responsible of innovative projects for pharmaceutical industry culture media.

Pieta IJzerman-Boon, MSD, The NetherlandsAssociate Director Quantitative Sciences/Center for Mathematical Sciences-EuropePieta C. IJzerman-Boon received her education at the Uni-versity of Twente, the Netherlands. In 1995 she obtained her M.Sc. degree in Applied Mathematics, followed by a Ph.D. in Statistics in 1999. She joined MSD after her PhD. In 2011 she moved to the non-clinical statistics group in the company, where she currently works as a senior statis-tician at the Center for Mathematical Sciences.

Prof. Edwin van den Heuvel, University of Technology, Eindhoven, The NetherlandsEdwin obtained his Ph.D. in 1996. He started as a consult-ant in industrial statistics and afterwards he became head of the statistics department at MSD. Since 2010 he is full-time professor Medical Statistics at the UMCG and since October 2014 he is Professor at the TU/e department of Mathematics and Computer Science will be closely in-volved with the development of the Data Science Center Eindhoven (DSC/e).

Scott Kaszuba, QC Manager, Pfizer, USAScott Kaszuba studied Biology at the University of Massa-chusetts at Lowell. He has been working at the Andover MA facility for fifteen years working first for Wyeth Phar-maceuticals, which was later acquired by Pfizer. In his cur-rent position, Scott is the manager overseeing all non-testing activities performed within the QC Microbiology group.

Dr Gerald Kindermann, F. Hoffmann – La Roche, Basel, SwitzerlandDr Gerald Kindermann is “QA and GMP Compliance Lead for global QC” working in the Global Quality Group at Roche. Before that he held several positions within Roche,

amongst others Group Leader Quality Control and Quality Manager for the Supply Center.

Di Morris, Audit Manager CAG, GSK, United KingdomDi Morris worked more than 6 years as Midicines Inspector for the UK Department of Health. After 4 years of consul-tancy in Quality Assurance and as QP, she joined GSK in 2015. She has a broad experience in regulatory require-ments, microbiology and quality topics.

Dr Antje Motzek, Quality Assurance, Labor L+S AG, Bad Bocklett, GermanyAntje Motzek studied molecular and cell biology in Mainz and Erlangen-Nürnberg. She worked then as scientist at the Institute for Human Genetics in Mainz. After further trainings in QM and project management she is employed in the Quality Assurance of Labor L+S AG since 2016.

Dr Youwen Pan, QC Scientist/Microbiologist at Genentech, USAYouwen studied at the Lanzhou University and the North Carolina State University Biology and Microbiology. After his Ph.D. he worked as research scientist at Baxter. Since 2013 he is employed at Genentech, where he is involved in Rapid Microbiological Methods Development; Global Change Control and Global CAPA.

Dr Petra Parizek, Laves Arzneimittel, SwitzerlandPetra Parizek studied Biology at the University of Zurich and got her PhD in Biochemistry. Since 2013, she is work-ing at Laves Arzneimittel GmbH, Schoetz, Switzerland, a company with focus on biotechnological production of pharmaceuticals and food supplements. As Head of QC, Petra Parizek is responsible for the Quality Control of start-ing materials, In-Process-Control samples and products including microbiological, chemical and molecular biological analytics of QC as well as Environmental Monitoring.

Mousumi Paul, Director Manufacturing and QualityCenter of Expertise Microbiology, Merck, Sharp and Dohme, USAMousumi is the Global deployment lead for Rapid Micro Methods at MSD. She is also responsible for managing the Quality and Compliance initiatives within Center Of Exper-tise Microbiology. Prior to this role Mousumi worked in Biologics Quality Operations where she was the Quality lead for new product launches. Mousumi has over eight-een years of diverse experience from development through technology transfer, manufacturing and quality support for vaccines and biologics. Mousumi has directed transformation efforts and operational excellence projects focused on enhancements to sterility assurance. She holds a Master’s Degree in Microbiology and in Pharmacology and a Master of Business Administration degree in Management.

Information

Useful Information around the conference

GMP/GDP Certification Programme

This seminar is recognised within the GMP Certification Programme. By attending selected seminars, the participant can acquire an additional certificate. We offer the following modules:

� ECA Certified Validation Manager � ECA Certified QA Manager � ECA Certified API Production Manager � ECA Certified Quality Control Manager � ECA Certified Technical Operations Manager � ECA Certified Computer Validation Manager � ECA Certified Regulatory Affairs Manager � ECA Certified Microbiological Laboratory Manager � ECA Certified Sterile Production Manager � ECA Certified Biotech Manager � ECA Certified Pharmaceutical Development Manager � ECA Certified GMP Auditor � ECA Certified GDP Compliance Manager � ECA Certified Packaging Manager � ECA Certified Data Integrity Manager

On the internet at www.gmp-compliance.org you will find a text explaining which seminars are recognised for which certificates. Or you send an e-mail to info@gmp-compliance.org or a fax to +49-6221- 84 44 64 with the request for information about the GMP Certification Programme. We will then send you our brochure on the topic.

GMP/GDP In-house Training Courses

Are you interested in a GMP/GDP training course at your facility for a larger group of people? We offer practice-oriented GMP/GDP training courses on:

� Basic GMP - APIs (ICH Q7) - Medicinal Products - Biopharmaceuticals

� Quality Assurance � Quality Control � Validation/Qualification � Regulatory Affairs � Sterile Manufacturing � IT / Computer Validation � Good Distribution Practice (GDP) � Data Integrity

You will find a time schedule for each training course at www.gmp-compliance.com, button “Inhouse Training”. We also offer in-house training courses for Qualified Persons. Please contact us for more information: info@gmp-compliance.org

We will be happy to design further GMP training courses for you on request.

Lufthansa is Mobility Partner for all ECA Events

This seminar is recognised within the GMP Certification Programme. By attending selected seminars, the participant can acquire an additional certificate. We offer the following modules:

As an ECA course or conference attendee, you will receive up to 20% discounted travel fares (according to availability). And as Lufthansa German Airlines offers a comprehensive global route network linking major cities around the world you will most likely be able to benefit from these special prices and conditions.

And this is how it works: Once you registered for a course or conference you will receive a link together with your registration confirmation. Open-ing that link will take you to the Mobility Partner Program website where you can enter a code in the “Access to Event Booking” area you will also receive. This will take you into an online booking platform* that will auto-matically calculate the discount offered or provide you with an even bet-ter offer if another promotional fare is available.

We look forward to welcoming at one of our next events – and we already wish you a pleasant flight!

*Please note: You may have to enable pop-ups on the Mobility Partner Program website – otherwise the booking platform window will not open.

What are the ECA Foundation and the ECA Academy?

The European Compliance Academy Foundation (ECA Foundation) is an independent professional organisation chaired by a Scientific Advisory Board with members from the pharmaceutical industry and regulatory authorities.

The ECA Foundation’s goal is to support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances. The ECA Academy offers professional basic and advanced education (training) programmes.

All services offered by the ECA Academy and with regard to ECA Academy Memberships are solely managed by Concept Heidelberg (a leading Euro-pean training and information services provider). The ECA Foundation is conceptual sponsor of the ECA Academy.

Reservation Form (Please complete in full)

European Microbiology Conference 25-26 April 2018, Vienna, Austria Workshop Data Integrity in Microbiology 24 April 2018, Vienna, Austria European Microbiology Conference AND Workshop 24-26 April 2018, Vienna, Austria

* Mr * Ms

Title, first name, surname

Company Department

Important: Please indicate your company’s VAT ID Number Purchase Order No. if applicable

Street / P.O. Box

City Zip Code

Country

Phone / Fax

E-Mail (Please fill in)

If the billing address deviates from the specification to the right, please fill out here:

CONCEPT HEIDELBERG P.O. Box 10 17 64 Fax +49 (0) 6221/84 44 34

69007 Heidelberg Germany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.microbiology-conference.orgwww.gmp-compliance.org

DatesWorkshop Data Integity in MicrobiologyTuesday, 24 April 2018, 09.30 - 17.00 h (Registration and coffee 09.00 – 09.30 h)

European Microbiology ConferenceWednesday 25 April 2018, 09.00 – 17.30 h(Registration and coffee 08.30 – 09.00 h)Thursday, 26 April 2018, 08.30 – 16.15 h

VenueAustria Trend Parkhotel SchönbrunnHietzinger Hauptstr. 10-141130 ViennaAustriaPhone +43 (1) 878 04 0Fax +43 (1) 878 04 630parkhotel.schoenbrunn@austria-trend.at

Fees (per delegate plus VAT)European Microbiology ConferenceECA Members € 1,590APIC Members € 1,690Non-ECA Members € 1,790EU GMP Inspectorates € 895The conference fee is payable in advance after receipt of invoice and includes confe-rence documentation, dinner on 25 April, lunch on both days and all refreshments during the conferences. VAT is reclaimable.

European Microbiology Conferencecombined with Workshop Data Integrity in MicrobiologyECA Members € 2,080APIC Members € 2,180Non-ECA Members € 2,280EU GMP Inspectorates € 1,140The conference fee is payable in advanceafter receipt of invoice and includes confe-rence documentation, dinner on 25 April, lunch on three days and all refreshments during the conferences. VAT is reclaimable.

Workshop Data Integrity in MicrobiologyECA Members € 790APIC Members € 840Non-ECA Members € 890EU GMP Inspectorates € 445The conference fee is payable in advanceafter receipt of invoice and includes confe-rence documentation, lunch on 24 April and all refreshments during the conference. VAT is reclaimable.

AccommodationCONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the event. Reservation should be made directly with the hotel. Early reservation is recommended.

RegistrationVia the attached reservation form, by e-mail or by fax message. Or you register online at www.microbiology-conference.org.

Conference LanguageThe official conference language will be English.

Organisation and ContactECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 34info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content:Mr Axel Schroeder (Operations Director) at +49 (0) 62 21/84 44 10 or via email at schroeder@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Mr Niklaus Thiel (Organisation Manager) at +49 (0) 62 21/84 44 43 or via email at thiel@concept-heidelberg.de.

General terms and conditionsIf you cannot attend the conference you have two options:1. We are happy to welcome a substitute colleague at any time.2. If you have to cancel entirely we must charge the following processing fees: Cancellation • until 2 weeks prior to the conference 10 %,• until 1 weeks prior to the conference 50 %• within 1 week prior to the conference 100 %.

CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERGwill not be responsible for discount airfare penalties or other costs incurred due to a cancellation. Terms of payment: Payable without deductions within 10 days after receipt of invoice. Important: This is a binding registration and above fees are due in case of cancellation or non-appearance.

If you cannot take part, you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee, even if you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (re-ceipt of payment will not be confirmed)! (As of January 2012).

Privacy Policy: By registering for this event, I accept the processing of my Personal Data. Concept Heidel-berg will use my data for the processing of this order, for which I hereby declare to agree that my personal data is stored and processed. Concept Heidelberg will only send me information in relation with this order or similar ones. My personal data will not be disclosed to third parties (see also the privacy policy at http://www.gmp-compliance.org/eca_privacy.html). I note that I can ask for the modification, correction or deletion of my data at any time via the contact form on this website. ri/

0702

2018

Yes, I will take part in the social event on 25 April