Keeping up with the increasing and evolving safety and pharmacovigilance obligations around the globe can be a major challenge.
In this webinar, the speaker will discuss upcoming changes in global drug safety regulatory requirements and will demonstrate how Bioclinica’s drug safety regulatory intelligence tool, RITrace, can improve efficiencies and help you remain compliant.
Join the webinar to learn more about:
- The global outlook on drug safety and the current regulatory environment
- The new clinical trial Regulation EU No 536/2014
- Eudravigilance ISO ICSR updates
- Bioclinica’s tool to improve efficiency and remain compliant
- Management of the cloud-based tool
Nicole Baker, EEA QPPV, Director Drug Safety, Bioclinica, Inc.
Nicole Baker, PhD, EEA QPPV, Director of Drug Safety for Bioclinca Safety & Regulatory Solutions, provides strategic, operational and scientific leadership for clinical, post-marketing and QPPV projects, covering multinational companies with products at different stages of their lifecycle. She is located in Bioclinica’s Dublin office (Republic of Ireland). The Republic of Ireland’s membership of the EU is unaffected by the Brexit vote.
Nicole brings over three years of experience as EEA QPPV and over 15 years of experience in key therapeutic areas such as: vaccines, transplantation, metabolic, autoimmune and infectious diseases gained within Academia, industry, regulatory agency and CRO. She has extensive expertise in global and EU legislation, along with guidelines for regulatory affairs, pharmacovigilance and clinical trials.
Nicole’s extensive experience includes: MAA, IBs, DSURs, PSURs/PBRERs, PADERs, signal detection and risk management, company core safety information and labelling updates, PV agreements and PSMFs.
Nicole holds a PhD in Medicine/Rheumatology, an MSc in Biomedical Sciences/Immunology and a BSc in Biological Sciences.Message Presenter
Who Should Attend?
C-level and senior professionals responsible for quality and drug safety/pharmacovigilance.
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with financial lifecycle, safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.
Bioclinica’s Post-Approval Research division, a niche specialty clinical service provider, is dedicated exclusively to post-approval research. Our focus is in designing and conducting post-approval research for observational studies, post-marketing commitments, and large, simple trials. We also provide unparalleled expertise in post-approval safety studies. We offer comprehensive, innovative, technology-driven, cost-effective solutions with full-service capabilities for Pharmaceutical, biotech, and medical device companies.