PHARMACOVIGILANCE TRAINING III Edition

PHARMACOVIGILANCE TRAINING

III Edition Madrid 2 – 3 Jun 2022

After the successful previous editions, PVpharm is organizing a face-to-face training in Madrid on 2-3 Jun 2022. Don’t miss the III Edition! This training is targeted to Pharmacovigilance professionals. The objective is to provide professional knowledge on this area.

As un update, this year, participants will have the opportunity to send their questions in advance to the speakers!

This year we will focus on: QPPV day-to day activities (post-marketing and clinical safety), PRAC, RMP, Safety Referrals, PV in Patient Support and Market Research programmes, Integration of PV systems, Auditing PV, News and updates from the EMA, IDMP, EVDAS and Signal Management… and much more!

Download the brochure here! (Coming very soon)

Agenda

Registration form here!

KEY TOPICS

QPPV day-to-day activities
PV in global and local context
PRAC (Pharmacovigilance Risk Assessment Committee)
Safety Referrals
RMPs
IDMP
Clinical safety
Pharmacovigilance
Business models and integration of PV systems
Patient safety
Pharmacovigilance with innovative, generics and biosimilar products
PV in Patient Support and Market Research programs
EVDAS and Signal Management
Auditing PV local functions, service providers and partners
News and updates from the EMA (impacting PV functions)
Your own input (please send questions in advance to the speakers!)
Much more…

COURSE OBJECTIVES

This year, the 3^rd edition of the PV Training come with outstanding speakers with many years of experience in pharmacovigilance. They will help the participants to improve their performance and knowledge in PV. The new training will focus on different areas both from the industry and the regulatory perspective.

As an update, this year attendees will have the opportunity to send their questions in advance to the speakers, therefore, they will leave the course with all the information and questions solved!

As in previous editions, this training provides a fantastic environment to both improve your skills in PV and to socialize with other PV colleagues. Don’t miss this networking opportunity.

Please, see the agenda to review the objectives of the presentations!

FACULTY

Doris Irene Stenver

Medical Doctor. Member of the PRAC (Pharmacovigilance Risk Assessment Committee) at the EMA from July 2012 to February 2019. Previously, Chief Medical Officer at the Danish Medicines Agency and member of the EU Pharmacovigilance Working Party (1998-2012). Her regulatory experience comprises all aspects of pharmacovigilance, including scientific evaluation of drug safety issues, development of risk management strategies, policies and guidelines, provision of scientific advice to the pharmaceutical industry, and communication to health care professionals and the public. During 12 years (1986–1998) she worked as a physician at university hospitals in the Copenhagen area. Specialist in internal medicine. Her clinical experience also covers haematology, cardiology and infectious diseases. Currently, Doris I. Stenver is the founder of Unique Advice, an independent consultancy specialized in pharmacovigilance.

Hervé Ghislain Dhellot

Herve Dhellot is Medical Doctor, who has been working as QPPV and Global Head Pharmacovigilance at PharmaMar for the past 8 years, in Madrid. He has an extensive experience in the pharmaceutical industry, in which he has been working for 19 years in pharmacovigilance. Prior to working in pharmaceutical industry, he worked for few years as a physician in hospital, in France. Doctor Hervé Dhellot has worked for Roche and Sanofi Aventis, in pharmacovigilance before joining PharmaMar.

Jørgen Matz

Jørgen Matz, MSc, PhD, PgD is the Head of Global Pharmacovigilance & Drug Safety for InsudPharma, Madrid, Spain which is a healthcare company with business units for worldwide manufacturing, development and marketing of branded, generic and biotechnological products. Dr. Matz has several years of experience from working with drug safety & pharmacovigilance. He has a background as an experimental pharmacologist. In recent years he focussed on implementing pharmacovigilance systems tailored to support a continuous benefit-risk assessment of marketed products.

Alberto Molero

Alberto Molero is a pharmacist with professional experience in the UK in Hospital Pharmacy and in Pharmacovigilance. He is currently working as Local Pharmacovigilance Contact Person in Lilly Spain.

Calin Lungu

Dr. Lungu has worked for more than 20 years in drug development, clinical research, pharmacovigilance and quality assurance. He has done over 140 PV audits. Since 2004 he is a EudraVigilance trainer and trained more than 250 Eudravigilance and XEVMPD courses at the EMA, selected European cities and also in the US. He has also trained from 2008 to 2012 the EudraVigilance Data Analysis System course at the EMA and including participants from the EMA and the National Competent Authorities.

José Alberto Ayala Ortiz

José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) has been working more than15 years in Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and Electronic transmissions. Besides his day-to-day Pharmacovigilance work as a consultant and PV auditor, he is trainer of EVWeb, XEVMPD and the DIA Signal Management training courses. He provides EU QPPV services and local QPPV in Spain for Pharmaceutical Companies and other consultancies through PVpharm, were he is the CEO.

REASONS TO ATTEND

Improve your knowledge on Pharmacovigilance EU Regulations.
Get real examples on how other experienced PV professionals organize and manage the activities in the PV department.
In deep review of the QPPV function in a MAH (post-marketing and clinical safety commitments). From theory to real life examples.
Understanding the PRAC: overview and in deep review of those activities with major impact on the MAHs: Safety Referrals procedures and Risk Management activities.
Learn how other MAHs organize pharmacovigilance activities in Patient Support and Market Research programme.
Stay tuned with the last news from EMA. Understand the implications for MAHs.
Get updated on EVDAS.
Improve your signal detection process.
Learn from real examples how to harmonize a PV system for different business models.
Learn about auditing PV.
Send your questions in advance to the speakers.
Solve your doubts in the proper forum.
Improve your PV operations and compliance.
Get to know what you are doing properly and what you need to improve.
Feel more confident in your pharmacovigilance day-to-day.
Enlarge your PV network.

Who should attend

Professionals from MAHs
Senior Managers and Pharmacovigilance managers
QPPVs and LSOs
Pharmacovigilance Officers/Drug Safety Specialists
Directors/CEOs of CROs
Regulatory/Inspection/Audits departments
Anyone working in areas affected by Pharmacovigilance operations
Pharmaceutical industry specialists
People aimed to get a background in Pharmacovigilance

What the training includes

2 days training
Presentations in digital format
Lunches, refreshment breaks and networking

AGENDA

Day 1: 2-June-2022
8:30-9:00	Welcome and registration
9:00-9:30	Introduction and overview of the agenda Jose A. Ayala Ortiz
9:30-11:00	Overview of activities in The Pharmacovigilance Risk Assessment Committee (PRAC) PRAC and Safety Referrals Doris I. Stenver In this presentation an overview of the activities covered by the PRAC mandate will be provided, including the legal framework and guidelines, the composition of the committee, its basic principles and tool box. All the major procedures dealt with by the PRAC will be described in brief, whilst the most complex procedure – the safety referral procedure – will be explained in detail, exemplified with real life case examples.
11:00-11:30	COFFEE BREAK
11:30-13:00	The day-to-day in the pharmacovigilance department of a MAH, QPPV perspective (I) – Clinical Safety Hervé Ghislain Dhellot In this presentation the speaker will talk about activities performed on his day-to-day as a QPPV. Hervé will talk about his experience, organization of the activities in the pharmacovigilance and clinical safety department, the challenges the QPPV faces and some tips based on his experience. He will contextualize his presentation in two different parts: clinical safety activities (Part I) and post-marketing commitments (Part II).
13:00-14:00	LUNCH BREAK
14:00-15:30	The day-to-day in the pharmacovigilance department of a MAH, QPPV perspective (II) – Post-marketing Hervé Ghislain Dhellot (Part II of previous presentation)
15:30-15:45	COFFEE BREAK
15:45-17:00	EMA updates impacting Global and Local PV functions Calin Lungu The latest updates from the EMA will be covered during this presentation, with special focus on XEVMPD, IDMP, GVPs among others.
17:00-17:15	Questions and Answers

Day 2: 3-June-2022
9:00-10:30	Pharmacovigilance in Patient Support Programs and Market Research Alberto Molero In this presentation, Alberto Molero will explain the role pharmacovigilance plays in Patient Support Programs and Market Research. He will explain how to deal with these programs and be in compliance with the pharmacovigilance regulation. Alberto will talk from his experience with these programs as the Local Contact Person for Pharmacovigilance of an international company.
10:30-11:00	COFFEE BREAK
11:30-12:15	EVDAS and signal management José Alberto Ayala Ortiz Updates on EU GVP Module IX and the use of EVDAS for signal detection in the MAH context.
12:15-13:00	PRAC and Risk Management Doris I. Stenver In this presentation the focus will be on the risk management activities on the PRAC agenda. Building on the overview presentation on day 1 this presentation will go more into detail with regard to procedural aspects of risk management. The recent revision of the GVP module aims at making the RMP a more dynamic document, which is subject to change during the life cycle, as more experience is gained. Besides it is important to be aware of specific requirements for the generics and biosimilars. Real life case examples will be presented.
13:00-14:00	LUNCH BREAK
14:00-15:30	Global management of patient safety in an international pharmaceutical company: I. Harmonizing a PV system for multiple business models II. Previous fallacies and misguided beliefs dictate Modus operandi Jørgen Matz In this presentation, Jørgen Matz will address the complexity of administrating PV systems for different development and business purposes in support for the manufacturing B2B model, marketing of branded innovative and generic products and the new era of biosimilar therapeutics. In the second part, he will talk about PV as a whole new science that has grown up around patient safety to try to explain the many circumstances, situations and occurrences that can put patients at risk. It is not always a single issue that causes the problem, but a combination of factors.
15:30-15:45	COFFEE BREAK
16:00-17:00	Auditing PV local functions, service providers and partners Calin Lungu Challenges and specifics of audits to local PV functions, service providers and partners will be addressed, with real life examples. Special attention will be given to the documentation, conduct of the audit on site, cultural and human issues,
17:00-17:15	Questions and Answers

Location

The training will take place next June 2^nd and 3^rd in Madrid, Spain. Join us at the Hotel Emperador, located in the city center of Madrid, great location to host this training, to connect with the rest of attendees and to enjoy the city.

https://www.emperadorhotel.com

Registration fees

Registration fee includes two days training, refreshment breaks, lunches and training course material in digital format^*.

Standard: 1,200€
Reduced fee-SME^**: 1,050€
Early Bird (Until 20^th April): 950€

*21% VAT not included // ** Upon providing a valid SME number // *** Special fees for University students/unemployed (upon presentation of documentation): info at info@pvpharm.com

Registration form

Download the brochure here! (Coming very soon)

Day 1: 2-June-2022

Day 2: 3-June-2022