5 -6 February 2014, Vienna, Austria

Speakers

Jrgen BlattnerBSR, Germany

Hendrikus BoersmaUniversity Medical Center Groningen, The Nether-lands

Uday BhonsleInternational Atomic Energy Agency, Austria

Clemens DecristoforoMed. Univ. Innsbruck, Austria

Klaus EichmllerDistrict Government of Upper Bavaria Munich, GMP Inspectorate

Maria IngevaldssonPharmaceutical Inspector, Medical Products Agency, Sweden

Eric KastangoClinical IQ, Member USP Sterile Compounding Expert Committee, USA

Roel ThijssenGE Healthcare, The Netherlands

This course is recognised for the ECA GMP Certification Programme Certified Quality Control Manager. Please find details at www.gmp-certification.eu

Highlights

European Regulatory Developments - PIC/s Guideline, EP, and more

USP the US Point of View IAEA Quality Initiatives Authority Inspections Quality Challenges Practical Experiences on GMP Implementation Room Qualification Endotoxin Testing

Current Regulatory Developments and

Practical Experiences

Radiopharmaceuticals

Quality - Safety - GMP Requirements

During this conference representatives of regulatory authorities and pharmaco-poeial experts will present the current development of radiopharmaceutical regulations and their experiences during the inspection of manufacturing estab-lishments.

Furthermore, speakers from nuclear medicine departments from universities and hospitals will show their experiences with GMP implementation. You will become acquainted with possible solutions for the special challenges and prac-tical approaches on room qualification for GMP-compliant manufacturing.

The configuration of the speaker team provides you with the unique opportu-nity to discuss the current status and the future expectations with representa-tives of national authorities and the International Atomic Energy Agency (IAEA), pharmacopoeial experts, as well as professionals from universities, hospitals and engineering.

The manufacturing of radiopharmaceutical products confronts the producing establishment with a variety of challenges. On the one hand there is the chal-lenge by the contradictory requirements of quality and safety guidelines of phar-maceutical products and the standards of staff safety and radiation protection. On the other hand there are issues of small batch sizes, and short shelf life. The short shelf life necessitates fast transportation and application to the patient. These circumstances mean that classical requirements like sterility testing before release and application cannot be fulfilled.

This conference is aimed at the personnel of hospitals, pharmaceutical compa-nies, their suppliers and authorities who are involved in

Quality Control Quality Assurance Inspection and Audits Qualification and validation

in radiopharmaceutical manufacturing.

Developments of International Regulations Part 1 PIC/S Guideline P010 Annex 1 and 2 Annex 3

Developments of International Regulations Part 2 Introduction Annex 3 Impact of Annex 1 PICs Other European Regulations

US Sight Pharmacopoeial and Authority Expectations USP Chapter Pharmaceutical Compounding-Sterile Preparations USP Chapter Positron Emission Tomography Drugs For Compounding,

Investigational, And Research Uses FDA Guidance: PET Drugs Current Good Manufacturing Practice (CGMP)

Small scale in-house production of radiopharmaceuticals: Regulatory aspects in Europe

Basic knowledge of PET radiosynthesis, Regulatory background of in-house produced radiopharmaceuticals in

Europe Regulatory examples from European countries and practical implications Recent regulatory trends for in-house production of radiopharmaceuticals Example from an Austrian facility for in-house production of PET and thera-

peutic radiopharmaceuticals

Objectives

Background

Target Audience

Programme

Radiopharmaceuticals 5 - 6 February 2014, Vienna, Austria

Cleanrooms for Radiopharmaceuticals - Qualification and Requalification Regulatory Background Room Pressure ranges Safety Cabinets Controlled Parameters / Monitoring Criteria for the choice of measurement equipment Analysis of Results and Documentation

Inspections Experiences Industrial Manufacturing incl. FDG Inspection considerations Problems Typical deficiencies

Inspections Experiences TC Generators Inspections Common findings Typical deficiencies FAQ

Quality, Safety and GMP in radiopharmaceutical practice in our member states

Review of IAEA guidance documents on quality, safety and GMP in radio-pharmacy

Current status of radiopharmacy GMP compliance in IAEA member states International Pharmacopeia: Radiopharmaceutical monographs updating

in association with WHO IAEA initiatives in training and education in radiopharmacy training in Africa Global applicability of the IAEA radiopharmacy GMP training initiative

Sterile Radiopharmaceuticals and Endotoxins Radiopharmaceuticals within GE Healthcare Regulatory requirements for radiopharmaceuticals Different approaches to endotoxin testing Endotoxin testing within GE Healthcare

Small scale radiopharmaceutical production for clinical use and contract research

State of the art small scale production of radiopharmaceuticals under GMP. GMP produced Zr-antibodies for cancer research New validation approaches for small scale radiopharmaceuticals How can industries collaborate with hospitals for the use of radio-

pharmaceuticals in drug development and clinical trials

Radiopharmaceutical Preparations Quality Challenges General aspects of quality control and release procedures of radio-

pharmaceuticals Quality Control: technical and regulatory aspects European Pharmacopeia monographs including selected examples

On 05 February 2014 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

Social Event

Speakers

Dr. Ing. Jrgen BlattnerBSR GmbH, Oberhausen-Rheinhausen, GermanyJrgen Blattner studied process engineering at the techni-cal university Karlsruhe . After his degree he joined Pallas with focus on filter testing, generating and measurement of aerosols. From 1997 to 2003 he was employed at CAS. Since 2003 he has his own business for cleanroom quali-fication and monitoring.

Ass. Prof. Hendrikus H. BoersmaPhD, Clinical Pharmacist, Clinical Pharmacologist and Qualified Person, senior staff member, Departments of Nuclear Medicine and Molecular Imaging/ Clinical and Hospital Pharmacy, UMC Groningen, The NetherlandsHendrikus Boersma studied Pharmacy at the University of Groningen. 1996 1997 he was QA pharmacist at TRA-MARKO. 1997 he joined Slotervaart Hospital Amsterdam as project pharmacist. From 1998 2007 he was em-ployed at the Department of Clinical Pharmacy and Toxi-cology, University Hospital Maastricht with a visiting re-search position at the Department of Cardiology of the University of California, Irvine, USA. His current position is Clinical Pharmacist, Clinical Pharmacologist, Qualified Person and senior staff member at Departments of Nu-clear Medicine and Molecular Imaging/ Clinical and Hospital Pharmacy of UMC Groningen and Assistant Pro-fessor, Faculty of Medicine, UMC Groningen.

Ass. Prof. Clemens DecristoforoUniversity Innsbruck, AustriaClemens Decristoforo worked 1991 -1997 as Radiophar-macist at Clinical Department of Nuclear Medicine Inns-bruck, Austria. After his graduation he was as Post Doc Marie Curie Fellow at the Nuclear Medicine Research Laboratory, St Bartholomews Hospital, London. In 1998 he joined the Clinical Department of Nuclear Medicine Innsbruck. Between 2009 and 2010 he was as Radiophar-maceutical Scientist at the Industrial Applications and Chemistry Section, Division of Physical and Chemical Sciences, of the IAEA. In his current position, he is Radi-opharmacist at the Clinical Department of Nuclear Medi-cine Innsbruck and tutor at the Medical University Inns-bruck, Austria. He is a member of the Editorial Board of the European Journal of Nuclear Medicine and Molecu-lar Imaging (Springer), the Editorial Board of European Journal of Nuclear Medicine and Molecular Imaging Re-search, Chairman Radiopharmacy Committee of the Eu-ropean Association of Nuclear Medicine (2006-2011)and Member of Expert Group 14 European Pharmacopeia (EDQM, Strasbourg).

Klaus EichmllerDistrict Government of Upper Bavaria Munich, GMP Inspectorate, GermanyAfter working in the pharmaceutical Industry Klaus Eich-mller joined the District Government of Upper Bavaria in Munich. Since 1996 he is working in the field of GMP Inspections of manufacturer of medicinal products and importers. He is Deputy Head of the Central Surveillance of Medicinal Products in Bavaria.

Uday BhonsleRadiopharnaceutical Scientist, IAEA, Vienna, AustriaPostgraduate qualification in Radiopharmacy, Nuclear Medicine Sciences and Biophysics. Worked as a Radiop-harmacist and also as a Nuclear Medicine Clinical Scien-tist for 22 years in the National Health Service, UK. Set up a number of PET and SPECT radiopharmacies and Mo-lecular Imaging Centres internationally. Joined Nuclear Applications Division of the International Atomic Energy Agency (IAEA) as a Radiopharmaceutical Scientist in 2010. Special interests, GMP and QMS in Radiopharma-cy, cost sensitive education and training initiatives in de-veloping countries.

Maria IngevaldssonPharmaceutical Inspector, Medical Products Agency, SwedenMaria Ingevaldsson holds a Masters degree in pharmacy from Uppsala University. Since 2002, she has been work-ing for the Medical Products Agency in Sweden. She is responsible for inspections in areas such as clinical nu-clear laboratories, extemporaneous production at phar-macies and blood establishments. Prior to that she worked at pharmacies mainly with extemporaneous pro-duction and hospital pharmacy.

Eric S. KastangoM.B.A., B.S.Pharm., FASHP, President/CEO, Clinical IQ, LLC, USAMr Kastango received his Bachelor of Science degree in pharmacy from the Massachusetts College of Pharmacy and Allied Health Sciences and his Master of Business Administration degree from the University of Phoenix. He completed 65 hours of training in nuclear pharmacy at Purdue University and 80 hours of didactic training for the Six Sigma-Green Belt certification that he started with BD Medical Systems. Since 1980, he has practiced phar-macy in a number of practice settings, including hospi-tals, community, and home care, in a number of different of roles, including the Corporate Vice President of Phar-macy Services for Coram Healthcare Corporation. He has also managed a FDA-registered cGMP manufacturing op-eration for Baxter Healthcare Corporation. He is an active member and Fellow of the American Society of Health-care Pharmacists and served on the USP Sterile Com-pounding Committee from 2005-2010 and was recently re-elected to the 2010-2015 USP Council of Experts, Compounding Expert Committee and served until April 2013. He is currently an Expert Consultant to the USP.

Roel ThijssenCoordinator QC Microbiology, GE Healthcare, The NetherlandsRoel Thijssen holds a bachelors degree from the Fontys University off Applied Sciences. He worked for 6 years at MUMC+ Maastricht University Medical Centre as Lab technician IVF. Since 5 years he now is employed at GE Healthcare as Coordinator QC & Site Microbiologist. He is a member of the Global Microbiology Expert Group and the GE Healthcare, Sterility Assurance Group.

wa/vers1/080509

Founded in 1978, CONCEPT HEIDELBERG is the leading organiser of seminars on pharmaceutical production, quality control, quality assurance and GMP in Europe. This year more than 240 events will be organised by CONCEPT HEIDELBERG. ECA has entrusted CONCEPT HEIDELBERG with the organisation of its events.

This conference is recognised within the GMP Certification Programme Module "Quality Control Manager". By attending selected seminars, the participant can acquire an additional certificate. We offer the following modules:

Validation Manager (ECA) QA Manager (ECA) API (Production) Manager (ECA) Quality Control Manager (ECA) Pharmaceutical Engineering/Production Manager (ECA) Computer Validation Manager (ECA) Regulatory Affairs Manager (ECA) Microbiological Laboratory Manager (ECA) Sterile Production Manager (ECA) Pharmaceutical Development Manager (ECA) Biotech Manager (ECA)

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.

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 Foundations 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 European training and information services provider). The ECA Foundation is conceptual sponsor of the ECA Academy.

By participating in one of the ECA Academy Conferences or Courses you will automati-cally become a ECA Academy Individual Member for two years - free of charge. More information about ECA Academy can be obtained on the Website http://www.gmp-compliance.org

During the membership, you enjoy a 200,- discount on the regular participation fee of any European Conference or Course presented by the ECA Academy. In addition you will receive the GMP Guideline Manager Software with a large number of guidelines, e.g. EC Directives, FDA Guidelines, ICH Guidelines.

As an ECA course or conference attendee, you will receive up to 20% discounted trav-el fares (according to availability). And as Lufthansa German Airlines offers a compre-hensive 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 re-ceive a link together with your registration confirmation. Opening 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 plat-form that will automatically calculate the discount offered or provide you with an even better 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!

About CONCEPT HEIDELBERG

GMP Certification Programme

What are The ECA Foundation and the ECA Academy?

How Do You Become Member of ECA?

What Are the Benefits of ECA?

Special offer with Lufthansa

DateWednesday 05 February 2014 , 09.30 - 17.30 h(Registration and coffee from 09.0 09.30 h)Thursday, 06 February 2014, 09.00 14.00 h

VenueTHE IMPERIAL RIDING SCHOOL VIENNARENAISSANCE HOTEL VIENNAUngargasse 601030 Vienna, AustriaPhone +43 (1) 711 75 0Fax +43 (1) 711 75 8143 Conference feesECA Members 1,490.-*APIC Members 1,590.-*EU GMP Inspectorates 845.-*Non-ECA Members 1,690.-*The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments.

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 conference. Please use this form for your room reservation to receive the specially negoti-ated rate. Reservation should be made directly with the hotel. Early reservation is recommended.

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

Conference languageThe official conference language will be English.

Organisation and ContactCONCEPT HEIDELBERGP.O. Box 10 17 6469007 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:Axel Schroeder (Operations Director) at +49-62 21/84 44 10 or per e-mail at schroeder@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Mr Ronny Strohwald (Organisation Manager) at +49-62 21/84 44 51, or per e-mail at strohwald@concept-heidelberg.de

*per delegate plus VAT. VAT is reclaimable.

Registration form (please complete in full)

Radiopharmaceuticals Quality, Safety and GMP Requirements5 - 6 February 2014, Vienna, Austria

0 Mr 0 Ms Title ___________

First name, surname

Company

Department

Important: Please indicate your companys 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 bill-to-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

wa/vers1/080509General Terms of BusinessIf 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 % of the registration fee.- until 1 week prior to the conference 50 % of the registration fee.- within 1 week prior to the conference 100 % of the registration fee.

CONCEPT 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 will 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. You are not entitled to participate in the conference until we have received your payment (receipt of payment will not be confirmed)! (As of January 2012)

Easy Registration

Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:info@concept-heidelberg.de Internet:www.gmp-compliance.org

wa/vers1/11102013