Mission Statement
The safe transport of Radiopharmaceutical Products is a vital requirement for the daily practice of Nuclear Medicine. The radioactive material needs to be transported safely and effectively to meet this need. This requires a number of different parties to adhere to a set of regulations that can be open for interpretation
With the purpose of proactively addressing the issues associated with the transport of radioactive products, the NMEU members have created an ad-hoc Transport Expert Group. The group was set up to have a common understanding, and to define standards within the radiopharmaceutical industry within Europe for the safe transport of radioactive materials.
These standards for shipment and checking of packages and the control and audit of carriers used by the group are fundamental for the control of radioactive material. All members will adopt these standards for the most important aspects associated with the transport of radioactive products.
Original Main Aims
Define a common understanding of how we can guarantee the safety of transport and improve our standards whilst maintaining transport costs within acceptable limits.
Define a common ground for discussing with authorities on transport safety-related issues and for focusing future regulations on the really important issues.
Define a common standard that we want to be implemented by all carriers.
Define a possible platform for designing respective areas of responsibility and control with air carriers to avoid duplication of efforts possibly through an audit procedure.
Procedures to check parcels compliance before they leave a manufacturer’s premises.
Returns standard shared with the European Association for Nuclear Medicine (EANM).
Standards produced
- Dose Rate Measurement for Type A and Type B Packages for Transport.
- Return Procedure for Type A and B Packages.
- Security of radioactive material in transit.
Audit of carriers
The Expert group are collaborating with EITA, the European Isotopes Transport Association to secure the commitment of the Carriers to ensure the safe transport and delivery of radioactive material. The Expert group have developed a system for standard auditing of carriers throughout Europe.
The Nuclear Medicine Europe Transport Experts Working Group consists of manufacturers, transporters and a trade body.
The Group
Chairman: Claude Poliart
COO – ISI
Vice-Chairman: Juul Rijpkema
Manager Regulatory Compliance & Transport Security – Curium Group
Supervisor: Mart-Jan Blauwhoff
Scientific Marketing Director – Curium Group
Rob Dekkers
Global Logistics Manager SPECT/PET and Dangerous Goods Compliance – GE HealthCare
Henk Doornebos
Curium Group
Jean-Guy Dronneau
Head of Production Radiochemical and Supply – IRE
Juergen Gay
Senior CMC Expert Radiopharmaceuticals
Marc Grisard
Process Engineer – IRE
Andrea Hawerkamp
VP International Sales & Business Development – ROTOP Pharmaka
Monika Koczyk
Head of Logistics – RC POLATOM
Martijn Koenis
Manager Traffic & Customs – Curium Group
Sailesh Persand
Cyclotron Engineer – Siemens Healthcare Ltd.
Ingo Russnak
Group Leader SCM General/Deputy Head of Global SCM
Harun Seckin
Customer Supply Manager – Monrol
Rohen Schuring
Manager ‘Transport & Logistics’ Dangerous Goods Safety Advisor – NRG
Paul Rice
Chief Development Officer – PHSE
Activities
Nuclear Medicine Europe Position on the Proposed Revision to IAEA Safety Standard Series SSR-6 Revision 1, Regulations for the Safe Transport of Radioactive Material 2018 Edition, Table 2 A1 & A2 Values
The transportation of medical isotopes and radiopharmaceuticals relies on an international supply chain facilitated by the International Atomic Energy Agency (IAEA) Regulations for the Safe Transport of Radioactive Material, 2018 Edition (SSR-6) which provide a consistent framework for safe transport.
Medical radionuclides and radiopharmaceuticals used in nuclear medicine are typically transported in one of the following three types of packages: Excepted package, Type A package, and Type B package. The short half-lives of most medical radionuclides and radiopharmaceuticals require hourly and daily shipments from manufactures and nuclear pharmacies to healthcare providers for patient care. These shipments are made according to stringent regulations designed to protect the public and the environment from risks, as well as accidents that may occur during shipping.
Position paper on the Ban on Lead for the Transport of Radiopharmaceuticals
The European Chemicals Agency’s (ECHA) 11th recommendation to include lead metal in the REACH Authorization List raises significant concerns within the Nuclear Medicine community.
While the intention behind such regulations is undoubtedly to enhance safety and environmental protection, it is crucial to consider the potential challenges and consequences that may arise from the implementation of this ban.
Click here or the image to download the position paper.
Gilles Degauque, former chairman of NMEU’s Transport Experts Working Group, asked our members five general questions about how the coronavirus affected them.
The nuclear medicine sector, like everyone else, has faced and is still facing huge challenges during the coronavirus pandemic. NMEU’s Transport Expert Group surveyed its members to find out how it has affected the transport of radioactive material, from shipment and safety to controls and audits.
