On the 18th of February, we conducted the webinar “How Small to Medium Pharma can address the increasing Challenges in Safety Case Management”, in collaboration with Oracle Health Sciences and seQure.
The pharmaceutical industry faces new and more complex challenges, especially on Pharmacovigilance.
Pharmacovigilance must keep up with product innovation, advances in technology, changing regulatory requirements, increasing need for data collection and processing capabilities, higher data volumes, while at the same time delivering on their risk management responsibilities.
These trends are pushing small to medium Pharma companies to utilize high-end and reliable enterprise solutions in Pharmacovigilance. Technology plays a huge role, both before and after a drug is released to the market.
Which aspects shall be considered by small to medium pharmaceutical companies to define the out-of-box scenarios and achieve the best-fit solutions without compromising their business attributes and continually improve the safety capabilities and internal efficiencies?
Are high-end enterprise solutions affordable? How to redefine the context of “affordability”?
In the first part of this webinar, we will show you the biggest challenges that Pharmacovigilance groups are facing in 2022 and how Gold Standard Solutions can help small and medium pharmaceutical companies.
In the second part of the webinar, you will have a possibility to get an overview of Oracle Argus and understand how it is a good match for small and medium pharmaceutical companies.
We will explain the most important criteria you should take into consideration during the evaluation process of Gold Standard Solutions. A complex and sophisticated solution can be user-friendly, simple, easy-to-use, and designed with your company goals.
What you will learn:
- the biggest challenges for Pharmacovigilance in 2022.
- How high-end solutions, like Oracle Argus, are a good match for small and medium pharmaceutical companies (and not only for the big ones).
- Which criteria you should consider when you evaluate the best Gold Standard Solutions for your company.
Philip Sheridan has 17 years’ experience in pharmacovigilance, from working with CRO’s (IQVIA), Pharma (BMS, Abbott) and most recently as the Pharmacovigilance SME with Oracle Health Sciences. His current role is as Business Development Director for Pharmacovigilance & safety systems, which includes Southern European region. He held a BSc in Applied Physics & an MSc in Pharmacovigilance.
Pedro M. Lledó is a physician by training who has been participating in clinical research projects for more than 20 years as IT specialist, database administrator or clinical research data manager. Before joining Arithmos he held leadership positions within CROs and biotechnology companies as Head of Data Management and Biometrics.
Stefania De Santis
Stefania has been working in pharmacovigilance since 1985 and she is Director of Pharmacovigilance at seQure. Prior to joining seQure she held the position of Head of Corporate Drug Safety and qualified Deputy EU QPPV in a large pharmaceutical company where she managed the Pharmacovigilance Department ensuring timely and quality delivery of projects. During her career, she has been responsible for a variety of pharmacovigilance operations in both pre-registration and post-marketing settings, case processing, PSUR and DSUR preparation, ICSR/SUSAR electronic transmission to the EMA, safety database validation, safety variations, signal detection, RMPs development, SDEA/Safety Management Plans and liaising with regulatory authorities.
Stefania is a qualified EU-QPPV and certified by EMA for the use of Eudravigilance and XEVMPD.