Jan Smolka Email and Phone Number

Providing medical and ethical support for assigned products mainly concerning heart failure, developing medical programs as part of the medical plan and coordinate and implement these in local territories. Also increasing the value of the brand for all stakeholders with organizing a participating in non-interventional studies, real-life outcome studies, and comparative effectiveness research.

- Critical evaluation of results obtained from clinical trials/published literature/bioequivalence studies- Main focus on vaccines, antifungal agents, antivirotics and immunomodulating agents, previous experience with antidiabetics and NSAIDs - Assessment of pharmacokinetic and pharmacodynamic data of medicinal products- Assessment of efficacy and safety of medicinal products based on phase I - IV clinical trials and published literature data- Cooperation with other departments involved in medicinal product risk-benefit evaluarion and with other regulatory authoritis throughout EU- Providing scientific support Czech Republic representative in European Medicines Agency- Providing scientific advice regarding scientific and regulatory aspects of the submission- Cooperation with healthcare profesionals and scientific societies- Continuing education in various fields related to the evaluation of medicinal products- Participation in various advisory boards and bodies

- Preparing and updating Product Information of Anti-HIV and antiviral portfolio- Coordination of activities related to management of core Product Information and communication with EU, non-EU affiliates and internal partners (new registrations, RUP registrations, territorial extensions, maintenance)- Ensuring that quality standards and strict deadlines are met - Contribution to pharmacovigilance documents- Creation and contribution to company core safety information- Continual monitoring of drug legislation and evalutaion of scientific data

Preparing documentation for solid dose production - mainly operating list. Dealing with problems in pharmaceutical production - for example losses in the production, introducing new technologies etc. , collecting data from internal databases.