Becoming an EU QPPV

26 – 27 Sep 2022

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.

Pharmalex Logo

800 BGN / 410 EUR

Earlybird registration

950 BGN / 485 EUR

Regular registration

Agenda

Monday, 26 September 2022

The EU-QPPV

Agenda

Monday, 26 September 2022

The EU-QPPV

EEST
13:00
-
14:00
CEST
12:00
-
13:00
Registration
EEST
14:00
-
14:10
CEST
13:00
-
13:10
Welcome

Albena Eftenova, PharmaLex Bulgaria

EEST
14:10
-
14:30
CEST
13:10
-
13:30
Opening Introduction, key notes

Prof. Asena Serbezova, moderator

EEST
14:30
-
17:00
CEST
13:30
-
16:00
EU-QPPV - legal background and qualifications for the QPPV role; PV System oversight

Dr. Susanne Becker, PharmaLex Germany
Dr. Monica Buchberger, PharmaLex Germany

EEST
17:00
-
17:30
CEST
16:00
-
16:30
Coffee break
EEST
17:30
-
18:30
CEST
16:30
-
17:30
EMA connected systems

Dr. Calin Lungu, DDCS S.A.

EEST
18:30
-
19:00
CEST
17:30
-
18:00
Q & A Session

Speakers and Audience
Prof. Asena Serbezova

Agenda

Tuesday, 27 September 2022

The authority view

Agenda

Tuesday, 27 September 2022

The authority view

EEST
08:30
-
09:00
CEST
07:30
-
08:00
Registration
EEST
09:00
-
11:00
CEST
08:00
-
10:00
The EU Pharmacovigilance System Master File (PSMF)

Dr. Monica Buchberger, PharmaLex Germany
Dr. Susanne Becker, PharmaLex Germany

EEST
11:00
-
11:30
CEST
10:00
-
10:30
Coffee break
EEST
11:30
-
13:00
CEST
10:30
-
12:00
Pharmacovigilance System Master File (PSMF) - annexes, local PSMF, summary

Dr. Monica Buchberger, PharmaLex Germany
Dr. Susanne Becker, PharmaLex Germany

EEST
13:00
-
14:00
CEST
12:00
-
13:00
Lunch and Networking
EEST
14:00
-
15:30
CEST
13:00
-
14:30
QPPV Oversight & Compliance Management

Dr. Susanne Becker, PharmaLex Germany
Dr. Monica Buchberger, PharmaLex German

EEST
15:30
-
16:00
CEST
14:30
-
15:00
Coffee break
EEST
16:00
-
17:30
CEST
15:00
-
16:30
Audits and inspections of PV system

Angela Sebastiany, PharmaLex Germany
prof. Asena Serbezova

EEST
17:30
-
18:00
CEST
16:30
-
17:00
Q & A Session

Speakers and Audience
prof. Asena Serbezova

EEST
18:00
CEST
17:00
17:00
Closing remarks
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 1st 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 2nd 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.

Monica Buchberger

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.

Dr. Susanne Becker
Angela Sebastiany headshot

Angela Sebastiany

Director Pharmacovigilance Germany ‖ Head of PV Team (Frankfurt)
International Service Lead PER System Compliance
PharmaLex GmbH

Angela Sebastiany is Director Pharmacovigilance Germany ‖ Head of PV Team (Frankfurt) at PharmaLex GmbH. She has more than 10 years of experience in Pharmacovigilance (PV), PV Quality Management & Compliance. Angela has Pharmaceutical qualification and holds a Master’s degree in Nutritional Sciences. She is an International Service Lead, responsible for global PV system and PV service compliance at PharmaLex, Additionally, she has broad experience as GVP Auditor with audit activities performed worldwide. Among Angela’s core competencies are: set-up, assessment and improvement of local and global PV systems and processes, as well as ensuring compliance with quality related and regulatory PV requirements.

Dr. Calin A. Lungu

Chief Executive Officer of Drug Development Consulting Services (DDCS)

Dr. Calin A. Lungu is the Chief Executive Officer of Drug Development Consulting Services (DDCS), a pharmacovigilance quality assurance consulting firm located in Windhof, in the Grand-Duchy of Luxembourg. He has worked for 15 years in drug development, clinical research, pharmacovigilance and quality assurance. Dr. Lungu has worked for a biotechnology company since 1993, and since 1995, as an independent consultant. Since 1999, he founded Drug Development Consulting Services of which he is presently CEO and which provides services in the area of quality assurance for pharmacovigilance.

Dr. Lungu has conducted over 150 pharmacovigilance audits for various pharmaceutical companies as well as National Competent Authorities in the EU, has participated in the preparation, conduct and follow-up of various regulatory inspections in the area of pharmacovigilance in Europe, has advised several EU and non-EU pharmaceutical companies in establishing/improving a pharmacovigilance system in conformity with current regulatory requirements.

Dr. Lungu has been a Eudraviglance Trainer since 2004 and has trained more than 250 Eudravigilance and XEVMPD courses at the EMA and also in various countries and has participated in various pharmacovigilance conferences in the EU.  He is a master trainer for the EMA Clinical Trials Information Systems since November 2021.

Dr. Lungu has been a professional trainer in the use of the EudraVigilance Data Analysis System for European National Competent Authorities and the European Medicines Agency between 2008 and 2012, is currently training the use of EVDAS for MAHs and is performing EVDAS analysis for several MAHs.

He graduated from the Free University of Brussels, Belgium and became MD in 1992, the same year he joined the pharmaceutical industry.

Dr. Calin A. Lungu headshot
Prof. Asena Serbezova

Prof. Asena Serbezova

Pharmacovigilance expert

Prof. Asena Serbezova is a pharmacist with more than 20 years’ experience in pharmacovigilance both in clinical development and post-authorization phase.  She graduated from the Medical university-Sofia (1996) and she obtained PhD 10 years later in social medicine and organization of healthcare. In 2008, she returned to her alma mater university as an assistant professor of social pharmacy and pharmacoeconomics. In 2018, Asena Serbezova was appointed as full professor in the Department of health policy and management at the Faculty of public health, Medical university-Sofia. From 2014 to 2018, she was the Executive Director of the Bulgarian Drug Agency at the Minister of Health, and was also a member of the Management Board of the European Medicines Agency. In 2020, she was elected as a president of the Bulgarian Pharmaceutical Union. In December 2021, prof. Serbezova took the position of health minister in the newly formed government. Prof. Serbezova has Helen has over 25 years of experience within pharmaceutical marketing, quality assurance, pharmacovigilance and clinical site auditing, GMP&GDP auditing, Quality Management Systems (QMS) and regulatory compliance. After the appointment of a caretaker government in August of this year, Prof. Serbezova returned to the responsibilities of her main expertise in the field of pharmacovigilance, quality assurance and GXPs auditing including pharmacovigilance audits. Asena Serbezova is an author and co-author of more than 150 scientific articles, books and manuals in the field of quality assurance, pharmaceutical legislation, pharmacoeconomics, utilization of medicines and food supplements and auditing.

Registration

Contact

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

“The Venue” hall, Sofia Tech Park
111 Tsarigradsko shose Blvd., entr. B, Incubator Building, 1st floor
Sofia, Bulgaria

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