Radiopharmaceuticals. Quality - Safety - GMP Requirements. 5-6 February 2014, Vienna, Austria

Transcription

1 Speakers Jürgen Blattner BSR, Germany Hendrikus Boersma University Medical Center Groningen, The Netherlands Uday Bhonsle International Atomic Energy Agency, Austria Clemens Decristoforo Med. Univ. Innsbruck, Austria Klaus Eichmüller District Government of Upper Bavaria Munich, GMP Inspectorate Maria Ingevaldsson Pharmaceutical Inspector, Medical Products Agency, Sweden Eric Kastango Clinical IQ, Member USP Sterile Compounding Expert Committee, USA Roel Thijssen GE Healthcare, The Netherlands 5-6 February 2014, Vienna, Austria 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 This course is recognised for the ECA GMP Certification Programme Certified Quality Control Manager. Please find details at

2 Radiopharmaceuticals 5-6 February 2014, Vienna, Austria Objectives During this conference representatives of regulatory authorities and pharmacopoeial experts will present the current development of radiopharmaceutical regulations and their experiences during the inspection of manufacturing establishments. 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 practical approaches on room qualification for GMP-compliant manufacturing. The configuration of the speaker team provides you with the unique opportunity to discuss the current status and the future expectations with representatives of national authorities and the International Atomic Energy Agency (IAEA), pharmacopoeial experts, as well as professionals from universities, hospitals and engineering. Background Target Audience The manufacturing of radiopharmaceutical products confronts the producing establishment with a variety of challenges. On the one hand there is the challenge by the contradictory requirements of quality and safety guidelines of pharmaceutical 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 companies, their suppliers and authorities who are involved in Quality Control Quality Assurance Inspection and Audits Qualification and validation in radiopharmaceutical manufacturing. Programme 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 <797> Pharmaceutical Compounding-Sterile Preparations USP Chapter <823> 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 therapeutic radiopharmaceuticals

3 Programme 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 radiopharmacy 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 radiopharmaceuticals in drug development and clinical trials Radiopharmaceutical Preparations Quality Challenges General aspects of quality control and release procedures of radiopharmaceuticals Quality Control: technical and regulatory aspects European Pharmacopeia monographs including selected examples Social Event 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.

4 Speakers Dr. Ing. Jürgen Blattner BSR GmbH, Oberhausen-Rheinhausen, Germany Jürgen Blattner studied process engineering at the technical 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 qualification and monitoring. Ass. Prof. Hendrikus H. Boersma PhD, Clinical Pharmacist, Clinical Pharmacologist and Qualified Person, senior staff member, Departments of Nuclear Medicine and Molecular Imaging/ Clinical and Hospital Pharmacy, UMC Groningen, The Netherlands Hendrikus Boersma studied Pharmacy at the University of Groningen he was QA pharmacist at TRA- MARKO he joined Slotervaart Hospital Amsterdam as project pharmacist. From he was employed at the Department of Clinical Pharmacy and Toxicology, University Hospital Maastricht with a visiting research 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 Nuclear Medicine and Molecular Imaging/ Clinical and Hospital Pharmacy of UMC Groningen and Assistant Professor, Faculty of Medicine, UMC Groningen. Ass. Prof. Clemens Decristoforo University Innsbruck, Austria Clemens Decristoforo worked as Radiopharmacist at Clinical Department of Nuclear Medicine Innsbruck, 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 Radiopharmaceutical Scientist at the Industrial Applications and Chemistry Section, Division of Physical and Chemical Sciences, of the IAEA. In his current position, he is Radiopharmacist at the Clinical Department of Nuclear Medicine Innsbruck and tutor at the Medical University Innsbruck, Austria. He is a member of the Editorial Board of the European Journal of Nuclear Medicine and Molecular Imaging (Springer), the Editorial Board of European Journal of Nuclear Medicine and Molecular Imaging Research, Chairman Radiopharmacy Committee of the European Association of Nuclear Medicine ( )and Member of Expert Group 14 European Pharmacopeia (EDQM, Strasbourg). Klaus Eichmüller District Government of Upper Bavaria Munich, GMP Inspectorate, Germany After working in the pharmaceutical Industry Klaus Eichmüller 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 Bhonsle Radiopharnaceutical Scientist, IAEA, Vienna, Austria Postgraduate qualification in Radiopharmacy, Nuclear Medicine Sciences and Biophysics. Worked as a Radiopharmacist and also as a Nuclear Medicine Clinical Scientist for 22 years in the National Health Service, UK. Set up a number of PET and SPECT radiopharmacies and Molecular Imaging Centres internationally. Joined Nuclear Applications Division of the International Atomic Energy Agency (IAEA) as a Radiopharmaceutical Scientist in Special interests, GMP and QMS in Radiopharmacy, cost sensitive education and training initiatives in developing countries. Maria Ingevaldsson Pharmaceutical Inspector, Medical Products Agency, Sweden Maria Ingevaldsson holds a Master s degree in pharmacy from Uppsala University. Since 2002, she has been working for the Medical Products Agency in Sweden. She is responsible for inspections in areas such as clinical nuclear laboratories, extemporaneous production at pharmacies and blood establishments. Prior to that she worked at pharmacies mainly with extemporaneous production and hospital pharmacy. Eric S. Kastango M.B.A., B.S.Pharm., FASHP, President/CEO, Clinical IQ, LLC, USA Mr 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 pharmacy in a number of practice settings, including hospitals, community, and home care, in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. He has also managed a FDA-registered cgmp manufacturing operation for Baxter Healthcare Corporation. He is an active member and Fellow of the American Society of Healthcare Pharmacists and served on the USP Sterile Compounding Committee from and was recently re-elected to the USP Council of Experts, Compounding Expert Committee and served until April He is currently an Expert Consultant to the USP. Roel Thijssen Coordinator QC Microbiology, GE Healthcare, The Netherlands Roel Thijssen holds a bachelor s 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.

5 About CONCEPT HEIDELBERG 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. GMP Certification Programme 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 you will find a text explaining which seminars are recognised for which certificates. Or you send an to info@ gmp-compliance.org or a fax to with the request for information about the GMP Certification Programme. We will then send you our brochure on the topic. What are The ECA Foundation and the ECA Academy? How Do You Become Member of ECA? What Are the Benefits of ECA? 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 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 automatically become a ECA Academy Individual Member for two years - free of charge. More information about ECA Academy can be obtained on the Website 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. Special offer with Lufthansa 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. 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 platform 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!

6 Easy Registration Reservation Form: CONCEPT HEIDELBERG P.O. Box Heidelberg Germany Reservation Form: info@concept-heidelberg.de Internet: Date Wednesday 05 February 2014, h (Registration and coffee from h) Thursday, 06 February 2014, h Venue THE IMPERIAL RIDING SCHOOL VIENNA RENAISSANCE HOTEL VIENNA Ungargasse Vienna, Austria Phone +43 (1) Fax +43 (1) Conference fees ECA 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. Accommodation CONCEPT 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 negotiated rate. Reservation should be made directly with the hotel. Early reservation is recommended. Registration Via attached reservation form, by or by fax message. Or you register online at Conference language The official conference language will be English. Organisation and Contact CONCEPT HEIDELBERG P.O. Box Heidelberg, Germany Phone +49 (0) 62 21/ Fax +49 (0) 62 21/ info@concept-heidelberg.de For questions regarding content: Axel Schroeder (Operations Director) at / or per at schroeder@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Mr Ronny Strohwald (Organisation Manager) at / , or per at strohwald@concept-heidelberg.de *per delegate plus VAT. VAT is reclaimable. If the bill-to-address deviates from the specification to the right, please fill out here: Registration form (please complete in full) Radiopharmaceuticals Quality, Safety and GMP Requirements 5-6 February 2014, Vienna, Austria 0 Mr 0 Ms Title First name, surname Company Department Important: Please indicate your company s VAT ID Number CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 6221/ Heidelberg Germany Purchase Order No. (if applicable) Street / P.O. Box City Zip Code Country Phone / Fax (please fill in) General Terms of Business If 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 wa/vers1/ 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) wa/vers1/