Becoming an EU QPPV

26 – 27 Sep 2022

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The safety of patients and public health have never been at such focus and importance before. Pharmacovigilance education is essential as adverse drug reactions (ADRs) are a serious health concern that contributes to avoidable patient burden and costly hospital admissions.

One of the steps that PharmaLex takes to enhance professional knowledge in pharmacovigilance is to offer a real-life training to Pharmacovigilance professionals who would like to become an EU Qualified Person for Pharmacovigilance for the regions – Bulgaria, Romania, Greece, and Macedonia.

Registration

will be open soon

Agenda

Day One: The EU-QPPV

Monday, 26 September 2022

Legal Background

Qualifications for the QPPV Role

EudraVigilance and xEVMPD certification

PV System Oversight

QPPV Oversight & Compliance Management

Day Two: The authority view

Tuesday, 27 September 2022

Expectations from the role of EU-QPPV

Common findings related to the EU-QPPV role in PV Inspections

Questions and answers

Who should attend?

This training is intended for the Pharmacovigilance professionals working within the pharmaceutical industry, academia, governmental institutions in pharmacovigilance, drug safety, quality assurance/quality control, and who would like to become an EU QPPV.

Level

3+ years PV experience

Objectives of the training

The aim of the training is to provide an insight into the role of the EU QPPV and to describe the path towards becoming an EU QPPV as well as to discuss the most critical processes of the PV system.

The training will be held in 2 days. The 1^st day will cover the EU QPPV oversight of the PV system and interfaces with national competent authorities, Local PV responsible persons and other departments. For the 2^nd day, topics with interactive workshops are planned, covering expectations for the role of EU-QPPV as well as common findings related to the EU-QPPV role in PV Inspections and audit findings.

Questions & Answers section is planned on day 2.

Upon successful completion of the training, attendees will receive a certificate

Speakers

The training will be conducted by experts who have first-hand knowledge of the most critical aspects affecting the PV sector. Throughout the training sessions, practical examples and frequently asked questions will be addressed through a rigorous and practical approach.

Dr. Monica Buchberger

Senior Director Pharmacovigilance ‖ Head of Department
Service Area Head PV Systems Outsourcing & PV Compliance PharmaLex GmbH

Dr. Monica Buchberger is Senior Director Pharmacovigilance at PharmaLex GmbH. She is a Pharmacist with more than 20 years of experience in the pharmaceutical industry in functions with global and local accountability. Monica also has wide experience in Pharmacovigilance, Regulatory Affairs and Quality Assurance.

Dr. Buchberger has EU-QPPV experience for Top 10 Pharma Company and has proven excellent leadership and management skills in international environments. Her main specialties are: international pharmacovigilance and regulatory legislation, mergers/acquisitions and spin-offs (portfolio integration, separation), leadership strategies.

As her core-values Monica points: solution-orientated, ownership, diligence, measured risk-taking, empowerment.

Dr. Susanne Becker

Director Pharmacovigilance, Germany
International Service Lead QPPV PharmaLex GmbH

Dr. Susanne Becker is Director Pharmacovigilance, Germany at PharmaLex GmbH. She has more than 20 years of experience in pharmacovigilance both in the area of clinical development and post approval settings. Dr. Becker is an expert pharmacovigilance professional including experiences as a QPPV in the EU/EEA. She is an EU-QPPV in various therapeutic areas including orphan, autoimmune, cardiovascular and infectious diseases.

Dr. Becker has hands-on experience in establishing and improving pharmacovigilance systems more specifically represented by in-depth knowledge in overseeing the benefit risk balance of medicinal products, leading signaling and risk management activities. She has successfully delivered projects in global PV teams.

In addition, Dr. Becker is medically qualified as Physician.

Mrs. Clara Borao

Manager Pharmacovigilance, PhamaLex Spain
SME in Art.57/XEVMPD and Eudravigilance

Clara Borao is Manager Pharmacovigilance at PharmaLex, Spain with more than 10 years in the Pharmacovigilance department. She holds BSc in Chemistry and MSc in Food Biotechnology.

Clara is also a Subject Matter Expert in the activities for the electronic submission of information on medicinal products using the eXtended EudraVigilance Medicinal Product Dictionary (Art.57/XEVMPD), and has wide knowledge in case management full process and Safety Database. Moreover, she is a Deputy Service Coordinator in EudravVgilance and EMA systems full registration process.

Clara’s specialties are consulting in EU pharmacovigilance legislation in ICSR and Products reporting requirements, EMA systems, Art.57 regulation and ISO IDMP implementation, ICSR and products processing, electronic reporting. She also has proven excellent coordination and communication skills with diverse work teams.

Clara’s core-values are: client-orientated, commited, collaborative and responsive.

Contact

Pharmalex Bulgaria

bulgaria@pharmalex.com

+359 2 4373779

www.pharmalex.com

As а contractual partnership (DZZD), BIОTECH ATELIER acts in full compliance with the Personal Data Protection Policy of its members
Personal data protection policy

Location

The Venue hall is a multifunctional space that offers the opportunity to hold conferences, seminars, trainings, workshops, team building activities. Its modern design provides various possibilities for transformation to accommodate different events regardless of the format – live or online. The Venue hall is located on the ground level in the Incubator building. Adjacent to it are smaller event halls, a co-working space, a restaurant and access to the Incubator’s inner English courtyard.

Address

111B Tsarigradsko shose Blvd., Sofia