2ND ANNUAL PHARMACOVIGILANCE & DRUG SAFETY SUMMIT
June 13–14th, 2019
The stringent regulations on safety monitoring increased the safety in data collection, analysis and regulatory surveillance. Adding to this the rising demand for drugs, the amplified need for novel therapeutics development via extensive clinical trials and the world population growth made drug manufacturers to start to pay more attention to Pharmacovigilance as public anxiety about safety increases.
Furthermore, the growth of exponential rare and chronic disease contributed to an increased need for drug development, therefore this led the industry to have a bigger focus on drug safety.
On this B2B event participants will have the chance to learn more about this challenging era and the latest developments in Pharmacovigilance and Drug Safety with the main key players in this field.
This event will be focusing on trends on Regulatory challenges, Signal detection, Data management, Risk management, Audit & Inspection and New technology applied to Pharmacovigilance procedures.
We invite you to discuss and debate these challenges in a dialogue amongst top professionals in Pharmacovigilance.
Key Practical Learning Points of the Summit:
• The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format
• Comply With FDA’s June 2018 Deadline for Combination Product Safety Reporting
• Regulatory Inspections – How can companies avoid critical and major findings?
• PSURs: Benefit-Risk Evaluations – The patient perspective
• Effectiveness checks for risk minimization measures
• The Role of QPPV
• What GVP auditors currently focus on?
• Increase transparency and heighten operational standards to ensure accurate ADR detection
• Applying data analytics in Pharmacovigilance processes to increase the speed of signal detection
• Ensuring data integrity and Compliance with CGMP
• What the New EU Data Protection Regulation (GDPR) will mean for PV?
• Good Pharmacovigilance Practices (GVP) Implementation
• Implementing and adopting global harmonization practices within a company
Who Should Attend:
CEOs / Presidents / MDs, CCOs/CMOs/CDOs, Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, and Managers specialising in:
• Assurance & Compliance
• Quality Assurance
• Data Analysis
• Clinical Data Management
• Medical Affairs
• Adverse Drug Reactions
• Drug/Product Safety
• Drug Development
• Clinical Safety
• Risk Management
• Patient Safety
• Signal Detection
• Signal Management
• Safety Surveillance
• Regulatory Affairs and Compliance
• PV Governance
• Safety Management
• PV Inspection and Audit Readiness
• Medical Safety
• Phase IV/Postmarketing Safety
• International and regional health authorities and regulators
• Pharmaceutical, Vaccines, & Biotechnology companies
• Clinical Research Organization (CRO) service providers
• Business Process Outsourcing (BPO) service providers
• Risk Management Software developers
• Pharmacovigilance Audit Firm’s
• Pharmacovigilance consultancy service providers
• Contract Research Organizations
• Adverse Event/Case Management Service Providers
• Safety Database Providers for Case Management
• Healthcare/Pharmacovigilance Consultants
• Healthcare Translation Agencies
• Technology Vendors/Portal Service Providers
For any enquiry on regards to special offers & group discounts please contact us directly at:
Rocio Castellanos started her carrer with the Pharmaceutical Industry in 2001 and since then she has hold different positions with the Quality Assurance Organization. Rocio’s area of expertise are on implementation and management of the risk strategy, utilizing audit and inspection intelligence to identify risk mitigation strategies and adherence to Pharmacovigilance regulations and activities (including GCP for clinical trial trials) in order to assure the quality and integrity of generated data. Rocio has presented at different conferences and she is an active member of the RQA organization (System Audit course tutor).
Dr Rama Diop has joined Novartis as PV manager in 2010 after 4 years of experience in Sanofi Medical team and 2 years practising as MD in the public sector. She has been promoted on 2013 to the Novartis (and its divisions) Regional Head Position for Africa managing Novartis PV system implementation in overall Africa. She holds a Doctorate of Medecine from the University Cheikh Anta Diop of Dakar as well as a University Diploma of Epidemiology of Bordeaux University. She is a happy mother of 3 girls.
Monika has 16 years experience in pharmaceutical industry, starting as a Clinical Research Associate for a multi-center, multi-national clinical trial. She has 13 years experience in planning, conducting and reporting of audits in the areas of GCP, GLP and Pharmacovigilance. In her role she is responsible for establishing and leading the PV System group within PV Governance (1 Training specialist, 2 PV System Specialists and 1 Senior Specialist PV Quality System). She is also responsible for maintenance of the Pharmacovigilance System Master File (PSMF), liaison with other departments, e.g. Clinical, Regulatory, Quality Assurance to provide timely updates of information and coordination of submission of consolidated PSMF to health authorities on request.
Dr. Sameer Thapar holds a doctorate of pharmacy (PharmD) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US and concurrently, holds an academic role of Professor, Drug Safety and Pharmacovigilance with a major US University. Dr. Thapar has over 20 years of experience in operations within the pharmaceutical, biotech, and CRO industries, with cross-functional experience in medical aﬀairs, clinical operations, quality assurance, and subject matter expertise in pharmacovigilance operations and compliance. He has built global departments and defended in successful FDA, MHRA, and EMA health authority inspections. Dr. Thapar is an active advisor in US based life science industry conferences and participates as an invited speaker and panelist in global industry conferences.
Sally Chen has got over 12 years of experience in pharmacovigilance and in individual case processing and risk management, with a proficiency in a variety of safety databases including ARISg, RSGT, ARGUS, help Oracle to complete Argus C installation including the Japanese module translate to Chinese module, and complete CFDA SAE report form configuration, ADR report form configuration, PSUR report configuration (cover sheet& event line listing).
Nikolina is a PhV Scientist and Director at NC Vigilance Ltd., a consultancy company offering post-marketing pharmacovigilance activities specializing in preparation of aggregate reports, Risk Management Plans (RMPs) and risk minimization tools, and development of algorithms for data retrieval. She started her career in pharmacovigilance in 2011 when she joined Teva\'s PSUR Writing Centre (TPC) where she was the lead author of many Periodic Safety Update Reports, Addendum to Clinical Overviews, US Periodic Adverse Drug Experience Reports, and RMPs. Her marked role was as a TPC representative in a Quality Team, a team set globally within Teva with the aim of improving data quality. She was also responsible for training of the newcomers. Nikolina is a pharmacist by background with work experience from a community pharmacy.
Catherine Harvey is a Senior Director in Clinical Safety and Pharmacovigilance in GlaxoSmithKline. One of her areas of interest is the design and deployment of real-world pragmatic effectiveness studies, and the collection, interpretation, and application of safety data from these studies. She has worked for over twenty-five years in the pharmaceutical industry in many areas of medicine development and in a variety of therapeutic areas. Prior to this, she held academic research and teaching posts in human physiology in the University of Alberta, Canada and the University of Oxford, UK.
Gema is an Associate Director in Lifecycle Safety in IQVIA. She is a biochemistry graduate with over 12 years of experience working in pharmacovigilance. Gema is currently EU QPPV and local national contact for Pharmacovigilance in Spain. She ensures oversight of the pharmacovigilance system and maintains oversight of the evolving safety profiles of assigned MAH products. During these years, Gema built up considerable practical experience in all aspects of pharmacovigilance including: preparation and maintenance of PSMF, ICSR processing & reporting, literature reviews; aggregate report management; signal detection; handling responses to Competent Authorities (including PRAC); audit and inspection activities.
Ricarda works as Head of Drug Safety and PoC Medical Information with more than 5 years of experience in effectively planning, developing and implementing Pharmacovigilance relevant activities, processes and strategy. She has the overall responsibility of all local Market Research and Patient Support Programs (MAPs). Ricarda is also involved with Local safety responsible and Back up Risk Management Implementation Coordinator for Switzerland and Liechtenstein.
As a physician Mate has started working in the field of pharmacovigilance since his graduation. First, he was medical advisor and reviewer at the Central Data Entry Site of Global Pharmacovigilance - AstraZeneca, later on, he joined Boehringer Ingelheim - Branch Office Hungary as national QPPV and local pharmacovigilance (PV) manager. In this role Mate was responsible for all PV relevant activities in the territory of Hungary. Besides the work he has also started his PhD studies in connection with tobacco, alcohol and medicine use among adolescents in 2013. Recently, Mate has involved pharmacovigilance in his researches as well. Furthermore, he is a part-time donor-screening physician at Hungarian National Blood Transfusion Services. Since the end of 2017 Mate has been working for Novartis Hungary as the Country Head of Patient Safety in Hungary and National QPPV. His team covers all pharmacovigilance tasks and responsibilities for Novartis Companies Hungary including Novartis, Sandoz and Alcon portfolio which means it is one of the biggest drug safety departments in the country.
Graduating in the faculty of Pharmaceutical sciences, Ain-Shams university in Egypt, Medhat Mahfouz started working as Quality Control Specialist at Arab Drug Company (ADCO) for 2 years. From 2012 he started to work as a pharmacovigilance specialist in Arab Drug company, was later appointed as deputy Qualified Person for Pharmacovigilance. In 2014, I was appointed as Qualified Person for Pharmacovigilance (QPPV), and appointed as QPPV for the Arab League. In 2015, Medhat was appointed of Head of Pharmacovigilance at Muticare Egypt for Pharmaceutical Industries, managing all the local activities envisaged in this area by the regulations and the company organization. Medhat holds responsibility for the coordination of post-marketing pharmacovigilance activities as well as clinical research, also taking on the role of QPPV consultant for different companies. Throughout his career, Medhat has been able to successfully merge the activities of 3 offices (Regulatory Affairs, Pharmacovigilance, Quality) into a single department with improved efficiency and operational effectiveness.