Speakers

Jrgen Blattner
BSR, Germany

Hendrikus Boersma
University Medical Center
Groningen, The Netherlands

Current Regulatory
Developments and
Practical Experiences

Uday Bhonsle
International Atomic Energy
Agency, Austria

Clemens Decristoforo
Med. Univ. Innsbruck,
Austria

Klaus Eichmller
District Government of
Upper Bavaria Munich,
GMP Inspectorate

Radiopharmaceuticals
Quality - Safety GMP Requirements

Maria Ingevaldsson
Pharmaceutical Inspector,
Medical Products Agency,
Sweden

5 -6 February 2014, Vienna, Austria

Eric Kastango

Highlights

Clinical IQ, Member USP

Sterile Compounding Expert
Committee, USA

Roel Thijssen
GE Healthcare,
The Netherlands

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

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

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

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.

Target Audience

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

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.

Speakers
Dr. Ing. Jrgen Blattner
BSR GmbH, Oberhausen-Rheinhausen, Germany
Jrgen 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. 1996 1997 he was QA pharmacist at TRAMARKO. 1997 he joined Slotervaart Hospital Amsterdam
as project pharmacist. From 1998 2007 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 1991 -1997 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 (2006-2011)and
Member of Expert Group 14 European Pharmacopeia
(EDQM, Strasbourg).
Klaus Eichmller
District Government of Upper Bavaria Munich, GMP
Inspectorate, Germany
After working in the pharmaceutical Industry Klaus Eichmller 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
2010. 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 Masters 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 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 Thijssen
Coordinator QC Microbiology, GE Healthcare, The
Netherlands
Roel 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.

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 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.

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 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.

How Do You Become

Member of ECA?

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 http://www.
gmp-compliance.org

What Are the Benefits of ECA?

Special offer with Lufthansa

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 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!

 Easy Registration
Form:
Reservation
CONCEPT HEIDELBERG

P.O. Box 10 17 64
69007 Heidelberg
Germany

Reservation Form:
+ 49 6221 84 44 34

Internet:
@ e-mail:
info@concept-heidelberg.de www.gmp-compliance.org

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

Date
Wednesday 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

Conference language
The official conference language will be English.

Venue
THE IMPERIAL RIDING SCHOOL VIENNA
RENAISSANCE HOTEL VIENNA
Ungargasse 60
1030 Vienna, Austria
Phone +43 (1) 711 75 0
Fax
+43 (1) 711 75 8143

Organisation and Contact

CONCEPT HEIDELBERG
P.O. Box 10 17 64
69007 Heidelberg, Germany
Phone +49 (0) 62 21/84 44-0
Fax +49 (0) 62 21/84 44 34
info@concept-heidelberg.de
www.concept-heidelberg.de

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.

For questions regarding content:

Axel Schroeder (Operations Director) at
+49-62 21/84 44 10 or per e-mail at
schroeder@concept-heidelberg.de.

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.

If the bill-to-address deviates from the

specification to the right, please fill out here:

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 Requirements

5 - 6 February 2014, Vienna, Austria
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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 willwa/vers1/080509

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/vers1/11102013