Detailed Programme
09:30 – 10:00 | Registration of participants
10:00 – 10:20 | OFFICIAL OPENING
- Year 2019: The transitions of pharmaceutical sector
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
11:00 – 11:25 | Hospital, doctor, pharmacist, patient – law and practical ties
- Who decides about the therapy
- Hospital
- Doctor
- Pharmacist
- Patient
- Biological therapy
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
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
12:25 – 12:45 | Online advertising of medical products
- Social network advertising
- Online advertising addressed to the specialists
- Influencers carried out advertising
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
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
14:20 – 15:00 | Electronisation of the medical products trade proccesses
- Electronisation of the medical products trade processes
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