EVENT – European Pharmacovigilance Congress 2022 | Milan, IT

The European Pharmacovigilance Congress organized by Pharma Education Center has become one of the most appreciated international PV meetings. The Congress, now in its sixth edition, is a unique opportunity to get the sight of different international stakeholders, to learn more about the new requirements, and new emerging challenges in Pharmacovigilance, and to discuss the possible strategies and solutions to address them.

 

The first two days, November 7th and 8th, will be virtual and provide a chance for worldwide experts and key opinion leaders to participate. Ergomed & PrimeVigilance Chief Information Officer, Shaun Hopgood, will speak on November 7th at 13:55 on the topic “The Digital Dilemma – the challenges of aligning pharmacovigilance process, regulatory compliance, and technology capabilities”.

Shaun Hopgood
Chief Information Officer, PrimeVigilance & Ergomed

The third day, November 10th will be a face-to-face meeting in Milan, where you will have the chance to meet and listen PrimeVigilance Head of Quality, Noelle Humphrey, invited as a speaker on the topic “Ensuring Successful Audits – The Challenges and Opportunities” scheduled at 12:05.

Noelle Humphrey
Head of Quality, PrimeVigilance

We also invite you to visit our booth #01 to meet our experts and commercial team.

Alessandro Di Ranno
Vice President, Business Development Europe
alessandro.diranno@ergomedplc.com

For more information about this event, visit https://www.pharmaeducationcenter.it/corsi/european-pharmacovigilance-congress/ 

If you have any questions or want to set up a meeting with the PrimeVigilance team during the The European Pharmacovigilance Congress 2022, email us at marketing@ergomedplc.com.

We look forward to seeing you there! 

ARTICLE – “Biosimilars: PrimeVigilance your Partner of Choice for Efficient and Cost-Effective Safety Surveillance”

 

With over 15 years of experience, PVL offers the unique advantage of a one-stop shop to support all safety requirements associated with the development, regulatory management, and post-marketing safety surveillance of biosimilars.

Author

 

Valerie Leray, Senior Vice President, Global Head of Project Management and Strategic Partnerships

 

Download Full Article

NEWS – Latest Pharmacovigilance Webinar open for registration

This webinar will focus on the activities that should be carried out for the establishment and maintenance of a pharmacovigilance system for marketing authorization holders based on quality standards that are detailed in Good Pharmacovigilance Practices. It will also describe the role of the Qualified Person Responsible for Pharmacovigilance in the EU (EU QPPV) as the crucial role in the performance of these activities within the marketing authorization holder’s pharmacovigilance system.

You will get insight into the regulatory framework as well as guidance on the structures and processes of a pharmacovigilance system.

Choose between one of 3 sessions available for this webinar on October 20th:
  • Session 1: 20 Oct, 6am ET / 11am BST / 12pm CEST
  • Session 2: 20 Oct, 10am ET / 3pm BST / 4pm CEST
  • Session 3: 20 Oct, 2pm ET / 7pm BST / 8pm CEST

Agenda:
  • Regulatory framework
  • Overall quality objectives for pharmacovigilance
  • Compliance management by marketing authorization holders / Specific quality system procedures and processes
  • Processes to monitor the performance and effectiveness of a pharmacovigilance system and its quality system
  • Role and responsibilities of the EU QPPV

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our expert speakers:

Jana Hyankova, MD
Senior PV Director, EU QPPV, UK QPPV


Jana Hyankova is an expert on pharmacovigilance with more than 15 years of working experience from several global pharma companies. Jana joined PrimeVigilance (former PharmInvent) in 2014 and currently holds the position of Senior PV Director in the QPPV Department. She serves as EU QPPV and UK QPPV for several clients and conducts PV audits as requested by clients. Prior to joining PrimeVigilance, she held managerial pharmacovigilance roles at Bristol Myers Squibb and PharmaSwiss SA after the acquisition of the company Valeant Pharmaceutical International. Jana has gained her medical education at Charles University in Prague. Outside of PrimeVigilance, Jana is chairing RQA Pharmacovigilance Committee and is also an active lecturer of the RQA, PIPA, ISoP, and Conforum.

Elena Alcaraz
Strategic Advisor, EU QPPV, UK QPPV


Elena joined PrimeVigilance in 2021 after 14 years of working in different pharma companies. She currently holds the position of Strategic Advisor in the QPPV Department, acting as EU QPPV and UK QPPV for several clients. She has a degree in Pharmacy from the Universidad Complutense in Madrid and a master’s degree in Pharmaceutical Industry. During her professional career, she has specialized in the field of product’s safety, focusing on Human Pharmacovigilance but also Veterinary Pharmacovigilance and Cosmetovigilance. She is an active member of the Spanish Association of Pharmacists of the Pharmaceutical industry and an active lecturer in different master’s degrees.

 

If you have any questions about our webinar please feel free to contact us.

 

NEWS – Article by PrimeVigilance Safety Experts focused on Medication Errors Reported with Methotrexate

Mistakes in the prescribing, dispensing, storing, preparing, and administering of medicine are the most common preventable cause of undesired adverse events in medication practice and present a significant public health burden. Read on and gain an in-depth understanding of the medication errors reported with methotrexate in the EU.

Authors
  • Ivona Bahnik Bisevac, PV Director of Benefit-Risk Management
  • Bojana Milasinovic, Senior PV Physician
  • Katarina Stamatovic, Medical Reviewer

Download Full Article

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