Programme TEST

Detailed Programme

09:30 – 10:00 | Registration of participants
10:00 – 10:20 | OFFICIAL OPENING
  • Year 2019: The transitions of pharmaceutical sector
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Irena Rej

Prezes Zarządu, Izba Gospodarcza FARMACJA POLSKA
10:20 – 11:00 | The deployment of Drugs Policy documents resolutions on 2018-2022 to the law
  • The drug refunds transitions
  • New regulations of pharmaceutical law
  • The transitions of pharmaceutical sector activities
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Juliusz Krzyżanowski

Senior Associate, Baker & McKenzie Krzyzowski i Wspolnicy sp.k.
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Paweł Hincz

Partner, Head of Life Sciences, Baker & McKenzie Krzyzowski i Wspolnicy sp.k.
11:00 – 11:25 | Hospital, doctor, pharmacist, patient – law and practical ties
  • Who decides about the therapy
    • Hospital
    • Doctor
    • Pharmacist
    • Patient
    • Biological therapy
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Paulina Kieszkowska-Knapik

Adwokat, Wspólnik w KRK Kieszkowska Rutkowska Kolasiński
11:25 – 11:50 | The regulations of clinical trials – where are we and where are we heading
  • Legislation (EU) nr 536/2014 – when will the usage start
  • The state of so called Polish about ordinance law
  • New FDA ordinance concerning submitted files in relation to a clinical trial
  • Scientific advice
  • Medical Research Agency draft
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Ewa Rutkowska

Adwokat, Wspólnik w KRK Kieszkowska Rutkowska Kolasiński
11:50 – 12:25 | Dietary supplements – advertisement and planned regulations
  • Planned advertisement transitions – the possibility of detailed joint regulations deployment
  • Web advertising
  • The Good Practice of Dietary Supplements Advertising codex – practice and future
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Noemi Chudzik

LL.M., Radca Prawny, Partner, Kancelaria Chudzik i Wspólnicy Radcowie Prawni
12:25 – 12:45 | Online advertising of medical products
  • Social network advertising
  • Online advertising addressed to the specialists
  • Influencers carried out advertising
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dr Andrzej Balicki

Partner, DLA Piper
12:45 – 13:00 | Coffee break
13:00 – 13:40 | The pharmaceutical sector tax issues
  • Payback and the risk-sharing instruments – the tax aspects of settlements
  • The most important changes of 2019 tax regulations
  • Key trends of tax inspections
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Szymon Bernat

Tax Manager w zespole Life Sciences w KPMG w Polsce
13:40 – 14:20 | New EU regulations governing medical products trade
  • Unrepeatable ID codes system(UDI)
  • European database Eudamed
  • Clinical evaluation of medical products transitions
  • New rules of medical products supervision after being brought on the market
  • The rules of cooperation with notified units transitions
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Michał Komar

Radca prawny, Associate w kancelarii D.Dobkowski sp.k stowarzyszonej z KPMG w Polsce
14:20 – 15:00 | Electronisation of the medical products trade proccesses
  • Electronisation of the medical products trade processes
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Mateusz Dończyk

Adwokat, COGENTS Plocke Skibicki Dończyk
15:00 – 15:40 | How to prepare for requirements of proposed law about collective entities accountability
  • Designed law requirements
  • Risk management system in pharmaceutical industry (compliance)
  • Creating of procedures, files, worker’s duties
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Jakub Misiak

Adwokat w Kancelarii Tomasik Jaworski sp. p.
15:40 - 16:40 | LUNCH / END OF CONFERENCE