Pharmacovigilance & Medical Information: An Integrated Approach
Webinar date & time: May 16th 15:00 CET
Join our webinar and learn how you can achieve this integration from our real-world experience.
Are you interested in learning about the benefits of integrating Pharmacovigilance and Medical Information? Then, join us for our upcoming webinar, where we’ll discuss the advantages of combining these two critical components of drug safety.
Don’t miss out on this opportunity to expand your knowledge and stay up-to-date with the latest trends in drug safety. Register now and take your Pharmacovigilance and Medical Information management to the next level!
This webinar explores the benefits of integrated Pharmacovigilance and Medical Information. We’ll discuss how you can achieve this integration by sharing our real-world experience. Shortly? We aim to help you successfully integrate these functions and realize their positive impact on your operations and patient outcomes.
Join us to learn how integrated Pharmacovigilance and medical information can benefit your organization and ultimately improve patient care.
Register here!
Olga Asimaki - CMD, PhD.
International QPPV / Head of Global Medical Information
Olga Asimaki is a certified Medical Affairs professional with extensive experience in all aspects of Pharmacovigilance and Medical Information. Olga is a post-doctoral Neuroscientist holding an MSc from King’s College London and a PhD in Pharmacology. Before joining Biomapas, Olga was Head of Pharmacovigilance and Medical Information at AbbVie, leading and developing pharmacovigilance/medical information teams and systems. During her career, she has worked with global teams to successfully launch, implement and maintain a global medical information system and its processes.
Setting up Medical Information In Europe?
Let’s talk how we can team up to conduct them effectively and ensure smooth processes.
Other content that might interest you:
What is a Safety Signal?
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.
Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions
PV legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each MAH to perform literature review in countries where their products are present. Compliance with mandatory requirements and guidelines is not always a simple task when local requirements and specifics come along. In this article, we will take a closer look at these challenges and specifics for local literature surveillance in different regions as EU, CIS and LATAM.
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)
On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.
