Zdeněk Chmelík Email & Phone Number

Prague, The Capital, Czech Republic

Head of quality assurance department, Responsibility for the project on global level, Executive management team member, Responsibility for implementation of Quality Management System, Shared responsibility for management of team of 70+ reviewers, Recording/assessment/answering of complaints/quality issues, QC of process updates/implementation of new projects, CAPA management, Audit attendance, Vendor qualification maintenance, Engagement in validation of database, Key Performance Indicators maintenance and analysis, Business Continuity and Disaster Recovery testing.

Prague, The Capital, Czech Republic

Management and medical monitoring of clinical trials:-country and centre feasibilities, KOLs management-regulatory and ethics committee submission-study set up, follow up, close-out, data clean-up-participation in on-site audits, inspections; -resources allocation, planning, timelines;-internal/external communication, reportingGCP trainer

Prague, The Capital, Czech Republic

-Acting as a sponsor of scientific medical knowledge, keeping pace with the development of medicine and medical science-Providing scientific and medical information compliantly in line with company standard operating procedures and local codes of practice, guidelines and laws in the respiratory therapeutic area (COPD and asthma)-Providing medical support to marketing/sales team (supervision of promotional material, trainings) -Keeping good professional contacts with Key External Experts-Organising and supporting Advisory Boards, External Experts’ Meetings-Providing scientific support of medical events (seminars, conferences, symposiums) including attendance at relevant congresses-Scientific / expert speaker at company sponsored programs (symposia, webinars, internal or external meetings)-Responding to unsolicited inquiries for medical information-Supporting implementation of pharmacovigilance activities-Supporting external scientific engagement, advocacy and medical education activities

In cooperation with PVM setup and maintaining of local pharmacovigilance system:-Safety data management within clinical trials - cooperation with investigators, CRA, Clinical Operation Managers, processing of SUSARs, DSURs, RMPs etc.-Safety data management within post-authorisation phase - spontaneous ICSR processing, non-interventional trials, compassionate use program in oncology, market researches, social media etc.-Drug Safety Trainings;-Quality Control of Safety Information;-Deputy contact for CA (LPV);

Hlavní Město Praha, Česká Republika

Oncology Referent:-local scientific contact for all oncology related issues;-monitoring of situation in oncology in CZE and SVK (epidemiological analyses, new therapies etc.);-country feasibilities; -scientific support for local team; -KOLs management; Management of Clinical Trials in following indications:-Metastatic Colorectal Cancer;-Chronic Lymphocytic Leukemia and Multiple Myeloma;-Post-Ischemic Stroke Functional Recovery; Activities related to the Management of Clinical Trials:-conception of protocol; -feasibility process (assessing recruitment potential);-study set-up and study follow up (recruitment, ensuring quality monitoring);-organization of local investigator's meetings, work with national coordinator;-participation in on-site audits, inspections; -safety reporting, narratives;-data clean-up, study close-out; -resources allocation, planning, timelines;-internal/external communication, reporting;

Responsibility for management and local implementation of the medical safety data reporting project particularly:-implementation of project on local level;-official medical contact for headquarter;-correctness of reported data from medical point of view;-training / support for CRA, investigators, medical reviewers;-writing of project related SOPs/OPMs;

-Management of projects in oncology - centre selection, negotiation with opinion leaders, communication with CA, communication with CRO;-CRA trainer-Responsibility for Pediatric Investigation Plan in psychiatry - key opinion leader selection, negotiation with CA;-Medical monitoring of international multi-centre clinical trials - neurology, psychiatry, diabetology, cardiology, osteology;

Responsibility for the project particularly:-main contact for all QA related topics;-on-site audits;-ensuring of compliance of all clinical trials activities with EU and national regulations and ICH-GCP;-management of CAPA (corrective and preventive action);-writing of new local OPMs; -training of staff on ICH-GCP and related internal SOPs/OPMs;

-Medical monitoring of international multicentre clinical trials with respect to ICH- GCP - neurology, psychiatry

Dispensing of both human and veterinary medications with and without medical prescription, providing of pharmaceutical care, monitoring of the prescriptions including the correct substitution of the medication, dealing with side effects and drug interactions, reporting of adverse drug reaction to the competent authority, optimization of the pharmacotherapy, communication with prescribing physicians.

Doctor Of Philosophy (Ph.D.), First Faculty Of Medicine

Doctoral studies of Preventive medicine. Epidemiology and epidemiological methodology, Cardiology, Internal medicine, Medical English.

Doctor Of Pharmacy (Pharm.D.), Faculty Of Pharmacy

Master study program extended by rigorous examination procedure: Human Pharmacology and Toxicology, Clinical Pharmacology, Pharmaceutical.

Clinical Pharmacy

Continuing education for healthcare professionals, Pharmaceutical Control of safety, quality, efficiency and cost-effective use.