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3rd Medical Teleinformatics Forum—“Procedures and Practice in Clinical Trials and Treatment Experiments”

The 3rd Medical Teleinformatics Forum, “Procedures and Practice in Clinical Trials and Treatment Experiments,” will be held on 23–24 January 2013 at the Cemed Conference Centre in Warsaw. The event is organized by Centrum Promocji Informatyki.

The conference is designed for the research, medical and academic communities, the pharmaceutical industry, and persons responsible for implementation of EU regulations on clinical trials in the member states.

The agenda of the forum will cover such issues as:

  • Standards in clinical trials with respect to scientific research and medical experiments
  • The role of universities and clinical hospitals in carrying out clinical trials
  • Risks and consequences of failure to prepare for direct implementation of the EU’s proposed Clinical Trials Regulation.

Our law firm will be represented by partner Karolina Stawowska, who heads the tax advisory team, and Marta Gadomska-Gołąb, an attorney on the life science team who specializes in healthcare law.

During her presentation, “Tax aspects that may arise in connection with contracts to conduct clinical trials,” Karolina Stawowska will discuss:

  • VAT exemption for clinical trials
  • Individual tax law interpretations confirming the VAT exemption
  • Tax issues of contracts with investigators
  • The tax authorities’ approach to the issue of sham contracts.

In a presentation entitled “Legal aspects of conclusion and content of contracts to conduct clinical trials,” Marta Gadomska-Gołąb will discuss:

  • Key issues when negotiating the wording of contracts, analysis of standard contract clauses, and comments most often raised by investigators and research centres
  • Issues of payments between the parties to the contract, including models for payment of fees and financing of healthcare benefits in clinical trials
  • Inspections, audits and monitoring of clinical trials in the context of the confidentiality of medical documentation.

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