IBA ACADEMYFROM TALENT TO EXPERTISE.

iba-radiopharmasolutions.com

Academy

Internship Your benefits:

Join h radiopharma team Live routine or R&D work hBe part of scientific community hAcquire GMP practices. h

The IBA academy offers a comprehensive training program held in a worldwide network of competence centers:

Well-trained people Maximize Your Potential

Your SiteYour benefits:

I h nvolve all your staffUse your system configuration hBe em h bedded in local context.

IBA CentersYour benefits:

Real live h hands-on trainingAccess to regional centers hMulti-competences hCustomized h and progressive.

From talent to expertise

1 | IBA Academy

Cyclotron operation

Your radiopharmaceutical production center

R&D Endless innovation

Site Management

Radiopharmaceutical production

Quality Control

Quality Assurance

From talent to expertise.

4 | IBA Academy

Site Management

Ensure profitability and efficient operation

The trainings were essential to help me manage the ever-increasing demands of a GMP-certified radiopharmaceutical production center. After the training, all the facets of a GMP-certified facility become clearer and I felt much more confident with my missions.

Stephane MairlotSite ManagerBeta+PharmaBelgium

General courses on administration and management � Fundamentals in cyclotron operation, FDG production, radioprotection and quality control � Advanced training in quality assurance covering all the aspects of FDG production: �

General understanding of GMP regulations 9 Regulations tailored to radiopharmaceuticals manufacturing practices 9 Project planning & staff organization 9 Risk analysis 9 Documentation, process description & control 9 Qualification&validationplanforFDGmanufacturingprocesses(fromproduct-inuptoproduct-out) 9 Flows(Peoples-Materials-Product) 9 Workinginclassifiedareas,environmentalmonitoring(HVAC) 9 Raw materials, warehouse management & shipping 9 Radioprotection & waste management 9 QualityControl&Batchrelease 9 IT system 9 Facility maintenance 9 Customerservices 9

InternshipinaGMP-certifiedradiopharmaceuticalsproductionintheIBAMolecularNetworkCenter � Best practices to run a GMP FDG production site. �

3 | IBA Academy

Cyclotron operation

Increase uptime and productivity Cyclotron equipment ¾ Progressive training from routine operation to maintenance and troubleshooting ¾

Start up Cyclone 9 ® training: daily operation and basic maintenance Advanced Cyclone 9 ® training: preventive maintenance and first line troubleshooting Expert Cyclone 9 ® training: fine tuning and advanced troubleshooting on specific sub-systems

Target system• Radio-frequency system• Vacuum system• Source system•

Radioprotection fundamentals ¾ Quality assurance fundamentals. ¾

Ourhands-ontrainingwasveryefficientinrealizingthe full operation possibilities of this versatile cyclotronin a short time; but it also allowed us to customize ourmaintenanceneedsaccordingtotheutilizationscenario.

Dr. Uwe HolzwarthScientific Officer Commissione Comunità Europee C.C.R. Italy

4 | IBA Academy

Radiopharmaceuticals production

Optimize global production process FDG equipment ¾

Start up FDG training: daily operation with Synthera 9 ®

Advanced FDG training: routine FDG production and troubleshooting 9 Internship: FDG production in GMP environment in the IBA Molecular Network Center 9

FDG processes ¾ Product-in up to product-out, warehouse management 9 Workinginclassifiedareas 9 Environmental monitoring 9 Cleaning procedures 9 Waste management 9

Routine production beyond FDG: FLT, NaF, FCH, F-dopa ¾ Radioprotection fundamentals ¾ Quality assurance fundamentals ¾ Production tools support. ¾ The training has been extremely helpful for me as

a radiochemist working in a GMP environment. The course provided me with the theoretical background about GMP rules as well as practise in [18F]-FDG production facility.A very comprehensive course, I highly recommend it!

Jolanta SzczurekRadiochemist - Physicist M.Sklodowska Curie Memorial Cancer CentreGliwice, Poland

5 | IBA Academy

Quality control

Guarantee safe product drugs delivery

Quality control equipment ¾ Quality control processes ¾ Quality control laboratory organization ¾ Quality assurance fundamentals. ¾

6 | IBA Academy

Quality assurance

Comply with regulations Advanced training in quality assurance covering all the aspects of FDG manufacturing: ¾

General understanding of GMP regulations 9 Regulations tailored to radiopharmaceuticals manufacturing practices 9 Project planning & staff organization 9 Risk analysis 9 Documentation, process description & control 9 Qualification&validationplanforFDGmanufacturingprocesses(fromproduct-inuptoproduct-out) 9 Flows(Peoples-Materials-Product) 9 Workinginclassifiedareas,environmentalmonitoring(HVAC) 9 Raw materials, warehouse management & shipping 9 Radioprotection & waste management 9 QualityControl&Batchrelease 9 IT system 9 Facility maintenance 9 Customerservices 9

InternshipinaGMP-certifiedradiopharmaceuticalsproductionintheIBAMolecularNetworkCenter ¾ BestpracticestorunaGMPFDGproductionsite. ¾

7 | IBA Academy

R&D endless innovation

Enlarge your horizon in Nuclear Medicine

System operation and maintenance for routine production (Nirta ¾ ® targets and Synthera®): [ 9 18F] FLT, NaF, FCH, F-dopa [ 9 11C] CO2, CH4, CH3I, Acetate, HCN [ 9 15O] O2, CO, CO2, H2O [ 9 13N] NH3

[ 9 124I] NaI, [64Cu] CuCl2 Development support ¾

In-depth use of Synthera 9 ® platform for tracer development Internship in the IBA network R&D centers 9 Be part of R&D community & joint development. 9

iba-radiopharmasolutions.com

ABOUT IBA IBA (Ion Beam Applications S.A.), is a cancer diagnostics and treatment company and the worldwide technology leader in the field of proton therapy. The company’s expertise lies in the development of next-generation proton therapy technologies and radiopharmaceuticals that provide oncology care providers with premium quality services and equipment, including IBA’s leading fully-integrated IntegraLab® system.

ABOUT IBA RADIOPHARMA SOLUTIONSBased on longstanding expertise, IBA RadioPharma Solutions supports hospitals and radiopharmaceutical distribution centers with their in-house radioisotopes production by providing them global solutions, from project design to the operation of their facility. In addition to high-quality technology production equipment, IBA has developed in-depth experience in setting up GMP radiopharmaceuticals production centers.

ABOUT INTEGRALAB® AND SYNTHERA®+IntegraLab® is a fully integrated solution combining equipment and services for the development of Radiopharmaceutical Production Centers. IntegraLab® includes the building designed with full regulatory compliance and the selection, integration, supply and installation of suitable high-technology equipment to match your radioisotope production goals.

Synthera®+ is a multi-purpose automated synthesizer for the production of 18FDG, other compounds (18FCH, 18FLT, Na18F, 68Ga peptides …). This smallest available module on the market is designed to accommodate a wide range of radiochemistry processes.

CONTACT US: Chemin du Cyclotron, 3 | 1348 Louvain-la-Neuve, BelgiumTel.: + 32 10 201 275 | Fax: + 32 10 47 59 58 | Info-cyclo@iba-group.com

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