The Secrets of the GMP production: Modern Approaches in Radiopharmaceutical Preparation
June 9 -10, 2022
ESMIT Learning Centre
Vienna, Austria
UEMS EACCME has granted the accreditation of 10 CME credits for this event.
COURSE CONTENT
The course focuses on the basics and fundamentals of Good Manufacturing Practice (GMP) through User Requirement Specification (URS), Validation, Deviations and Facility Planning. Moreover Radiation Safety, the question how to build up and manage a quality risk management system will be covered in the course. Additionally, it explains the increasing regulatory demands from laboratory work to clinical trials, going from laboratory notes to an Investigational Medicines Product Dossier (IMPD).
LEARNING OBJECTIVES
- Fundamentals of GMP
- Consequences of GMP Related Actions
- The Needs and Demands to get a Radiopharmaceutical into a Clinical Trial
- Points of Consideration when Planning a Radiopharmaceutical Facility
- Quality Risk Management
TARGET AUDIENCE
The target audience includes Radiochemists and Radiopharmacists with the interest to increase the understanding of GMP and the consequences of different GMP related activities (e.g. persons who have attended the EANM Radiopharmacy Courses) but as well Pharmacists who wants to gain a better understanding for GMP in the context of Radiopharmaceuticals. To sum up, persons working in the field of nuclear medicine who wants to gain a better understanding in GMP and what is needed for “First in Human” use, i.e. clinical trials.
PREPARATORY MATERIAL
Further information will be available soon
HOW TO REGISTER
The course allows a maximum of 20 participants. Registrations will be accepted on a first come
first serve basis.
How to register:
- Log in to your myEANM account.
- Click on the “eLearning platform” in the navigation bar on the left side.
- Once logged in on the platform, click on “Register Now!” in the green navigation bar. You will be directed to the online store.
- Click on “Advanced Courses in Vienna” and “The Secrets of the GMP production: Modern Approaches in Radiopharmaceutical Preparation”.
- Proceed to checkout.
REGISTRATION FEE
Course Fee € 950.-
Registration Fee includes:
- Electronic Course Book including all Slides
- Coffee & Lunch Breaks on each Course Day
Registration Fee does NOT include:
- Travel to the Venue
- Accommodation
MODE OF PAYMENT
Payment can be settled by
- Credit Card
- Cheques will not be accepted
CANCELLATION POLICY
Cancellations must be notified in writing to the EANM Office. Telephone cancellations cannot be accepted. Substitutions will be accepted if the name and e-mail address of the substitute are sent to the EANM Office 4 weeks prior to the event. In the case of cancellation 4 weeks before the course, we will refund you the fee less a € 100,- administration charge.
After this date, we cannot grant any refund for cancellations. Any refund will take place after the respective course. EANM will not be held liable for cancellation fees of hotels, airlines, or other means of transportation.
HOTELS
Hotel Ruby Marie (ESMIT Headquarter Hotel)
Website 
e-Mail 
+43 1 361 96 60 66 | 
5 minutes walking distance from ESMIT Learning Centre
Please note that it is highly recommended to book your accommodation at Ruby Marie´s as quick as possible due to the strong demand of bookings!
The Vienna Hotel
Website e-Mail +43 1 595 43 57 | 2 minutes walking distance from ESMIT Learning Centre
Intercity Hotel Vienna
Website e-Mail +1 469 610 360-8 | 5 minutes walking distance from ESMIT Learning Centre
Mercure Hotel Raphael
Website e-Mail +43 1 905 96 60 | 7 minutes walking distance from ESMIT Learning Centre
Mercure Hotel Westbahnhof
Website e-Mail +43 1 98 11 10 | 10 minutes walking distance from ESMIT Learning Centre
DIRECTIONS
Int. Airport Vienna to the ESMIT Learning Centre
Instructions by Public Transport | 30-40 minutes ride to ESMIT Learning Centre
ESMIT HQ Hotel Ruby Marie to the ESMIT Learning Centre
Map Image | 5 minutes walking distance to ESMIT Learning Centre
Railway Station “Westbahnhof” to the ESMIT Learning Centre
Map Image | 10 minutes walking distance to ESMIT Learning Centre
U3 Metro Station “Zieglergasse” to the ESMIT Learning Centre
Map Image | 5 minutes walking distance to ESMIT Learning Centre