CLINICAL MONITORING DURING & AFTER THE COVID-19 PANDEMIC:
REGIONAL CONSIDERATIONS, REGULATORY CHANGES AND OPERATIONAL CHALLENGES REGARDING THE CONTINUITY/PLANNING OF NEW STUDIES
The COVID-19 pandemic has disrupted businesses globally limiting travel, interactions and access to resources. The clinical research industry is no exception, having been greatly affected both from a study Sponsor and Participant standpoint.
Study Sponsors faced, are facing and will likely continue to face significant challenges related to supply chain, site operations and vital logistics such as staff availability and on-site clinical monitoring. In parallel, study Participants are dealing with mobility and travel issues as a result of lockdowns, social distancing and risk mitigation measures. The impact of COVID-19 is not uniform across regions however and one of the most important learnings in the current paradigm is the importance of identifying and developing new approaches as well as tailored solutions.
In this webinar, four highly experienced clinical research monitors based in Europe and the META (Middle-East, Turkey and Africa) regions will share:
1) Insights on the impact of COVID-19 on their day to day activities.
2) Updates on the situation in their region (regulatory requirements from local and regional bodies).
3) Effective approaches to dealing with challenges with a focus on regional hurdles and limitations.
4) How the new dynamic is affecting the already multifunctional nature of their role.
5) Perspectives on hybrid monitoring strategies aimed at minimizing or eliminating the need for on-site monitoring.
Wednesday June 17th 2020 at 4:00 pm EEST (3:00 pm CEST, 9:00 am EST)
Elias Sayias - Founder & CEO
ILIKOS Drug Development Solutions
Gili Amitai - Israel
Gili is a Senior CRA and clinical research consultant. She has 15+ years of experience working with pharmaceutical and medical device companies, handling feasibility/qualification, contracting, budget negotiations and study conduct oversight from start-up through close-out. Gili’s experience spans across a wide range of therapeutic areas such as Oncology, Ophthalmology, Cardiovascular disease, Infectious diseases, Orthopedics, Neurology, Genitourinary, Respiratory disease and others. Gili has also consulted companies on improving, optimizing and maintaining high quality work processes, managing international research and on how to prepare for different kinds of regulatory audits.
Henriette de Beer - South Africa
Henriette is a Senior CRA with a nursing degree and a wide therapeutic experience. She has been involved in clinical studies in South Africa and Africa (Botswana, Malawi, Uganda, Mozambique, Kenya, Tanzania and Zambia). Henriette brings 20 years of knowledge and experience as a clinical research professional in the pharmaceutical, device, and CRO industries. She has also an interest in Neonatal ICU studies. Her experience spans across global drug development, medical affairs, pharmacovigilance and regulatory affairs, auditing and quality assurance. She also has a proven track record in building, managing KOL’s in medical teams within South Africa. She has Phase I – IV and post marketing trial experience including investigator driven studies.
Olatx Alvariño Garay - Spain
Olatx is a Senior CRA who studied her pharmacy degree in University of Valencia (Spain), conducting the fourth year of studies at the University of Reims Champagne-Ardenne (France) and Pharmacist Pre-registration training at Azienda Ospedaliera di Perugia (Italy). She started her career working as a pharmacist in the United Kingdom and worked as well as a Hospital pharmacist in the NHS. After completing her master’s degree in Clinical Research in Barcelona she has been involved in different clinical trials from phases II to IV, including pediatrics population and rare diseases’ studies. Olatx has experience in EC/RA submissions in Spain as well as contract negotiations in Italy and Spain. She is a certified CRA according to the Italian DM since November 2011 and performed monitoring activities in Spain, Italy, United Kingdom, Germany, Sweden and Switzerland.
Dr. Patrick Tomasch - Germany
Dr. Tomasch is a clinical research consultant with a medical doctor degree and clinical practice in anesthesiology, internal medicine and radiation oncology. In the last 14 years he has been involved in clinical studies in Germany, Austria and other European countries. Dr. Tomasch has experience across a wide range of therapeutic areas such as: cardiovascular disease, gastroenterology, oncology, neurology, hematology etc. His experience covers clinical operations, regulatory & medical affairs and pharmacovigilance.