Subject Matter Experts
1. Dr. Axel Thiele; Pharmacovigilance compliance Auditing
Chemist Former Director and Professor at Federal Institute for Drugs and Medical Devices Head of Unit Risk Management Procedures and Pharmacovigilance Inspections
Since 1981- Employee at Institute of Drugs of the Federal Health Authority / Federal Institute for Drugs and Medical Devices at the Department Post Marketing Surveillance / Pharmacovigilance
Since 1986 - Head of Unit Risk Management Procedures, Pharmacovigilance Inspections
Since 2014 - Consultant Senior Expert Pharmacovigilance
Assistant Lecturer at the Rheinische Friedrich-Wilhelms-University Bonn and the Humboldt-University Berlin
2. John DR Jolley - FR Pharm S, FCQI CQP
Pharma Consult was founded by John Jolley in 2007 to bring together International Specialists from all aspects of Pharmaceutical Science and Technology to provide best practices solutions to developing new drug products in the International Healthcare industries.
PharmaConsult is registered as an SME with the EMA to assist Pharmaceutical Companies in a better understanding of the regulatory process and to guide the development of new medical products through a structured process to achieve a timely marketing authorisation with in the European Union.
Pharmaconsult UK Ltd has Affiliate organisations in; USA, Latin America (Buenos Ares), Far East (Singapore), and Middle East (Beirut- Riyadh- Dubai).
3. Monica Vassileva MPh: Clinical and Regulatory Compliance
Monica is a Qualified Pharmacist with over 10 years’ experience in CT monitoring, QA, International GXP compliance audits prior to EU&FDA inspections.
4. Emilia Apostolova MPh, PhD : Regulatory and Quality Management (QP)
Emilia has 10 years’ experience working as an assessor for the Bulgarian Drug agency and 15 years’ experience working in preparing CMC, eCTD regulatory submission. Emila is also registered as a European Qualified Person (QP).
5. Mariana Stoykova MD, Pharmacovigilance monitoring and regulatory compliance QPPV.
Mariana has 5 years’ experience working as an assessor followed by 10 years expertise in safety, EU QPPV.
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