Clinical Trials of New Drugs in Practice: Contracts, Budgets and Negotiation












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            style> <div class="cuni-clean-wrapper"> <!-- ANNOTATION --> <div class="cuni-annotation-he

            class="title-label">Annotation</strong> The lecture will provide practical insight into th
            clinical trials of new medicinal products and Sponsor–CRO–site collaboration. Students wil
            importance of effectively negotiating a Clinical Trial Agreement (CTA) and budget to prote

            principal investigator and study team, and learn why active negotiation can bring the site
            in additional funding. The lecture will also briefly introduce the regulatory framework an
            EMA, FDA and SÚKL. </div> <!-- CTA --> <div class="cuni-cta"> <div class="cuni-cta-text"> 

            the programme? Please submit your request via the form. Based on your request, we will arr
            and agree on a suitable date. </div> <a href="https://forms.cloud.microsoft/Pages/DesignPa
            origin=NeoPortalPage&subpage=design&id=2naS4DT5hkC_CIgWogQUopHVOtuey35BmpqUBmwwGdNUNEpDMUd

            target="_blank" rel="noopener" class="cuni-btn-link"> Arrange a date </a> <a
            href="mailto:ivo.svejkovsky@ruk.cuni.cz?subject=Question – Clinical Trials of New Medicina
            Practice&body=Dear Sir or Madam,%0A%0AI have a question regarding the programme Clinical T

            Medicinal Products in Practice.%0A%0A" class="cuni-btn-secondary"> Contact the lecturer </
            BASIC INFORMATION --> <h2 class="cuni-heading">Basic Information</h2> <ul class="cuni-para
            <li> <strong>Programme type:</strong> Lecture with time for discussion or a practical work

            <li> <strong>Primary target group:</strong> Bachelor's and Master's students and PhD stude
            <strong>Also available for:</strong> Academic staff, if required </li> <li> <strong>Durati
            3 teaching hours, as required </li> <li> <strong>Capacity:</strong> No limit </li> <li> <s

            strong> Czech, English </li> <li> <strong>Date:</strong> By arrangement </li> </ul> <!-- D
            DESCRIPTION --> <h2 class="cuni-heading">Detailed Description</h2> <p> The lecture will in
            practical operation of clinical trials of new medicinal products, covering the roles of th

            company (Sponsor), Contract Research Organisation (CRO) and research site, the phases of c
            research and work with the study protocol, as well as the contractual, financial and regul
            conducting a clinical trial. </p> <p> Particular emphasis will be placed on the Clinical T

            (CTA), its key provisions, payment terms, liability, data protection and the negotiation p
            the CRO, sponsor and hospital. Students will also learn about the preparation and negotiat
            trial budgets, the principles of TCPP, Fair Market Value and Anti-Bribery and Anti-Corrupt

            mechanisms for escalating budget requests to the sponsor. </p> <p> Practical examples will
            effective contractual and budget negotiations can protect the hospital, principal investig
            team and can significantly increase the funding available for conducting a clinical trial.

            framework for clinical trials and the roles of EMA, FDA and SÚKL will also be briefly intr
            lecture will include time for discussion and answering students' questions. </p> <!-- LEAR
            --> <h2 class="cuni-heading">What Participants Will Learn</h2> <ul class="cuni-outcomes-li

            clinical trials work in practice </li> <li> Who the Sponsor, CRO and site are and how they
            li> <li> What to look out for in a Clinical Trial Agreement (CTA) </li> <li> How a clinica
            is prepared and negotiated </li> <li> What can actually be influenced when negotiating wit

            li> <li> How to protect the interests of the hospital, principal investigator and study te
            What roles EMA, FDA and SÚKL play </li> <li> Practical examples of contractual and budget 
            </li> </ul> <!-- CONTACTS --> <h2 class="cuni-heading">Contacts</h2> <div class="cuni-pers

            <div class="cuni-contact-group"> <h4>Programme Coordinator</h4> <p> Mgr. BcA. Ivo Svejkovs
            MBA </p> <a href="mailto:ivo.svejkovsky@ruk.cuni.cz"> ivo.svejkovsky@ruk.cuni.cz </a> | <a
            +420771128396"> +420 771 128 396 </a> </div> <div class="cuni-contact-group"> <h4>Lecturer

            BcA. Ivo Svejkovský Ph.D., MBA </p> <p> Director of the Centre for Knowledge and Technolog
            Charles University </p> </div> <div class="cuni-contact-group"> <h4>Contact Person</h4> <p
            Svejkovský Ph.D., MBA </p> <a href="mailto:ivo.svejkovsky@ruk.cuni.cz"> ivo.svejkovsky@ruk

            <a href="tel:+420771128396"> +420 771 128 396 </a> </div> </div> </div>