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Related Experiment Videos

Ready for Germany's revised radiation rules?

Manfred Kurz1

  • 1Regulatory Strategy Department - H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark.

Critical Reviews in Oncology/Hematology
|February 18, 2019
PubMed
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Developing therapeutic immunoglobulins: European regulatory perspectives and implications.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy·2008
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Navigating clinical trial applications in Germany involving diagnostic radiation tests requires understanding the Federal Office for Radiation Protection (BfS) authorization process. Early planning and knowledge of procedural steps are crucial for timely oncology drug study initiation.

Area of Science:

  • Oncology
  • Radiology
  • Clinical Trials

Background:

  • Clinical trial applications (CTAs) in the EU are approved by national competent authorities.
  • The authorization process for diagnostic radiology in clinical studies, particularly for oncology drugs in Germany, is complex and not widely understood.
  • The Federal Office for Radiation Protection (BfS) independently evaluates these applications.

Purpose of the Study:

  • To clarify the authorization process for diagnostic radiology in clinical investigations involving investigational medicinal products (IMPs) in Germany.
  • To provide insights into the procedural steps and timelines associated with obtaining BfS clearance for oncology drug trials.
  • To aid project management and ensure timely study initiation by detailing regulatory requirements.

Main Methods:

Keywords:
AMGAuthorisationBfSClinical trialsCompanion diagnosticsEUGermanyIonising radiationLawMedical imagingOncologyRadiation protectionStrlSchGX-ray

Related Experiment Videos

  • Review of the regulatory landscape for clinical trials involving diagnostic radiation in Germany.
  • Analysis of the role and evaluation process of the Federal Office for Radiation Protection (BfS).
  • Identification of key procedural aspects and timelines relevant to CTA submissions involving radiology.

Main Results:

  • The authorization process for diagnostic radiology in oncology clinical trials in Germany involves the independent evaluation by the BfS.
  • Understanding the scope, procedural steps, and timelines is essential for successful project management and avoiding delays.
  • Recent legal changes and specific CTA aspects may streamline the BfS clearance process.

Conclusions:

  • Knowledge of the BfS authorization process is critical for the successful and timely initiation of multi-national oncology clinical trials in Germany.
  • Integrating Germany's specific regulatory requirements into drug development plans is important for global trial management.
  • Proactive planning and understanding of the BfS procedures can facilitate regulatory approval and expedite study commencement.