Michaela Šerudová

Global Regulatory specialist for clinical investigations and post-makret clinical follow-up studies in Europe for Edwards products (transcatheter heart valves, surgical valve technologies, transcatheter mitral and tricuspid therapies and critical care technologies) with focus on safety reporting

• To prepare, review and compile regulatory documents and submission packages for Clinical Investigations per effective regulations, guidelines and standards
• To coordinate submissions to National Competent Authorities and Ethics Committees
• To manage and support deficiency letter resolution
• Review and reporting of Serious Adverse Evens and Device Deficiencies to Regulatory Authorities and Ethics Committees
• Review of Safety Processes, Annual Safety Reports and Quarterly Reports for Clinical Investigations per MDR, National Regulations and MDCG guidelines
• Communication with Competent Authorities and Ethics Committies (BfArM, AGES, MHRA, ANSM,CCMO, Swissmedic, Swisstehics, Ministero della Salute, EOF, URPL)
• Leader for implementaion MDCG 2020-10/1 Guidance across Business Units inside the Company
• Participation in Shadowing project with Safety Team – Adverse Events, Device Deficiencies review, MedDRA coding, preparation of narratives for CEC Adjudication and DSMB
• Participation in EUDAMED testing project for CI/PS module organized by MedTech Europe
• To prepare and maintain Regulatory Playbook for Clinical Trials applications a and Safety Reporting
• To monitor and analyze changes in regulation, guidelines and standards to ensure compliance with requirements
• Regulatory Intelligence initiation and assessment

Part-time pharmacist with focus on communication with Health Insurance Companies and stock management. Consultant for veterinary pharmacology for public and veterinarians.

• Dispensing and sale of pharmaceuticals, medical devices and supplemntary assortment
• Professional counseling
• Stock management
• Communication with Health insurance companies
• Drug preparation – suppositories, capsules, creams, drops
• Administrative activities
• Specialist in veterinary pharmacology and therapy for animals

Regulatory specialist for pharmaceutical products (tablets, hard gelatin capsules) manufactured in Zentiva Prague manufacturing site.

• To prepare, review and compile regulatory documents and submission packages per effective regulations, guidelines and standards for MRP/DCP/NP procedures
• Publishing of sequences in eCTD/Nees/paper format for submission
• Communication with internal and external partners, coordination of submission procedure
• Change request process management
• Responsibility for product dossiers and database maintenance
• Legislation monitoring as regards a drug regulation as well as developmental trends in the branch for the purpose of implementation of DRA requirements into internal company standards

Local regulatory specialist for Czech Republic, Slovak Republic and Canada experienced in regulatory submissions for phase III and IV clinical trials

• Major therapeutic fields: oncology, dermatology (psoriasis, atopic dermatitis), neurology, ophthalmology
• Local Regulatory Contact for Clinical Trials and Non-interventional studies in Czech Republic, Slovakia and Canada
• To prepare, review and compile regulatory documents per effective regulations/ guidelines
• To prepare and complete submission packages for initial applications (including VHP and VHP Plus procedure ), amendments and notifications
• To coordinate submissions to National Competent Authorities
• To manage and support deficiency letter resolution
• To coordinate country label adaptations, review and translation
• Communication with SÚKL, ŠÚKL, Health Canada

Regulatory specialist for pharmaceutical products (tablets, soft gelation capsules, liquid dosage forms) manufactured in Teva Opava manufacturing site.

• Major therapeutic fields: oncology, hormonal therapy
• CTD submission - to prepare core package (module 3) for Variations, Annual Reports, New Registrations, Renewals
• To classify changes according to European Guidelines
• To review and analyze manufacturing site documents, ensuring completeness, regulatory compliance and consistency with regulatory documentation
• To prepare, review and compile regulatory documents per effective regulation/guidelines
• Regulatory consultant in change management process
• Administration of regulatory databases
• Approval o regulatory documents
• Dispatch of samples for regulatory purpose

• Pharmaceutical technology - manufacturing transfer in cytostatics division