V Edition Madrid & Online 27-28 May 2024
Pharmacovigilance Training V Edition, Madrid and Online 27-28 May 2024
After the successful previous editions, PVpharm is organizing a hybrid face-to-face/remote training in Madrid on 27-28 May 2024. Don’t miss the V Edition!
This training is targeted to Pharmacovigilance professionals. The objective is to provide professional knowledge in this area.
This year, participants will also have the opportunity to send their questions in advance to the speakers!
It would be possible to attend one or two days, either remote or face-to-face (limited seats!). This year, you would be able to attend the face-to-face at the same price as for the remote event!
We will focus on: Latest news from EMA, PRAC, Management of PV activities, QPPV responsibilities and oversight, Artificial Intelligence in Pharmacovigilance, PV in post-marketing and clinical safety, Benefit-risk management in Pharmacovigilance, experiences from PV inspections, updates from CTIS, EVDAS and Signal Management, Integration of PV systems… and much more!
Take a look at our confirmed Speakers below. Please notice that the course agenda and speakers are subject to modifications.
See the video of the previous edition.
COURSE OBJECTIVES
This year, the 5th edition of the PV Training come with outstanding speakers with many years of experience in pharmacovigilance. They will help participants to improve their performance and knowledge in PV. The new training will focus on different areas both from the industry and the regulators’ perspective.
The 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!
KEY TOPICS
- QPPV day-to-day activities
- PV in global and local context
- PRAC (Pharmacovigilance Risk Assessment Committee)
- Safety Referrals
- RMPs
- Pharmacovigilance
- Business models and integration of PV systems
- Patient safety
- Pharmacovigilance with innovative, generics and biosimilar products
- aRMM meausures, Dear Health Care Professional communications
- News on EMA, EudraVigilance, XEVMPD, EVDAS, Signal Management, CTIS
- Experiences from inspections and audits of the MAH, PV local functions, service providers and partners
- Artificial Intelligence in Pharmacovigilance
- Your own input (please send questions in advance to the speakers!)
- Much more…
Julia Appelskog
EU QPPV, Hear of EU QPPV Office, NOVAVAX
Global PV leader with over 19 years’ experience leading all facets of PV operations in healthcare sector. Demonstrated expertise in risk management plans (RMPs), periodic safety update reports (PSURs), post-marketing PV commitments, signal detection, PASS, PV inspections, GVP and GCP audits, Quality Management System, ARGUS/ARISg/Veeva safety databases, XEVMPD database and safety study protocols.
Strategic thinker with proven capacity to implement effective EU QPPV and PV strategies in adherence with industry best practices, trends, and legislation requirements to meet shared and individual goals. Adept at biological, biopharmaceuticals products, including vaccines, OTC, generics, cosmetics, and medical devices. Articulate and refined communicator establishing robust relationships with all levels of management.
Sofia Cavero
Senior Quality Specialist for Global Pharmacovigilance & Drug Safety, INSUD PHARMA
Pharmacist, with expertise in the quality system of the pharmacovigilance area. I add to the pharmacovigilance systems, and during GVPs inpections, my previous experience and knowledge in the quality assurance area of GMPs, GDPs, ISO Norms or medical devices at pharmaceutical multinational companies, where I’ve managed audits, service providers, procedures, corrective and preventive actions and the rest of the topics of a quality system. Project management in different countries.
Pilar Carrero
Vice President Global Safety, LEO PHARMA
Experienced and accomplished senior leader with a broad skill set spanning research, pharmacovigilance, quality assurance, training, IT/digitalization, and recently, medical information, across diverse global settings. Known for adaptability and building strong stakeholder relationships. Recognized as a creative thinker who focuses on the big picture while maintaining a results-driven approach. Successfully drove the implementation of a new safety database and established two new departments from scratch, showcasing adept change management, offshore operations, and stakeholder engagement.
Calin Lungu
Drug Development Consulting Services S.A. (DDCS), Luxembourg
Dr. Lungu has worked for more than 20 years in drug development, clinical research, pharmacovigilance and quality assurance. He has done over 150 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.
Elspeth McIntosh
Director /Consultant, CASTLE PHARMACOVIGILANCE
Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.
Jan Petracek
CEO, iVigee
Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV).
Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and the Queen’s Award for International Trade in 2019. He is also a lecturer, trainer, auditor, and advisor for various pharmacovigilance courses and initiatives, and a founder of the Institute of Pharmacovigilance. Jan’s mission is to elevate the recognition and competence of the pharmacovigilance profession, and to deliver sensible and pragmatic solutions to his clients and partners.
María Jose Reneses Setien
Deputy EU QPPV, TAKEDA
Engaged with Pharmacovigilance for more than 20 years, she is Deputy EU QPPV at Takeda. Supervises the management of the PSMF, oversight of the PV quality management system, ensuring PV inspection readiness. Together with the EUQPPV, maintains oversight of the EU PV system, serve as the Deputy Qualified Person for Pharmacovigilance for the European Union.
Marta Rodríguez Vélez
Quality Assurance in the Sterile Manufacturing Site (vaccines), LETI Pharma
Marta is a Biologist, Master’s Degree in Pharmaceutical Industry and Master’s Degree in Business Administration. Passionate about science, health and technology, and throughout her professional career she have specialized in the pharmaceutical and life sciences industry.
During her 20 years of professional life, she has always been linked to the pharmaceutical industry, managing projects related with basic research, clinical trials, quality assurance, compliance with GXP standards, regulatory affairs and pharmacovigilance.
Ricardo Andrade
Co-founder, Managing Director, OWL Pharma
Ricardo Andrade (PharmD; PGDip in Pharmaceutical Marketing Management and PGDip in Regulation and Evaluation of Medicines and Health Products) started working at INFARMED (Portuguese Health Authority) and then moved to the Pharmaceutical Industry. Since 2013 he is Co-Founder and Managing director at Owlpharma Consulting.
He has been working in the Pharmaceutical Industry for over 15 years, particularly in Pharmacovigilance and Regulatory Affairs. He acts as EU QPPV and Local Contact in Portugal for several national and international pharmaceutical companies. He has an excellent knowledge of Pharmacovigilance legislation and is a regular trainer at the request of several pharmaceutical companies.
His extensive experience in Pharmacovigilance includes Pharmacovigilance audits, signal management, implementation, and management of Pharmacovigilance systems.
José Alberto Ayala Ortiz
PVpharm CEO, Pharmacovigilance Consultant, QPPV, PV Auditor
José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) has been working for 20 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, where he is the CEO.
Reasons to attend
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Improve your knowledge on Pharmacovigilance EU Regulations.
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Get real examples on how other experienced PV professionals organize and manage the activities in the PV department.
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In deep review of the QPPV function in a MAH. From theory to real life examples.
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Learn how other MAHs organize pharmacovigilance activities.
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Stay tuned with the last news from EMA. Understand the implications for MAHs.
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Get updated on EMA, Eudravigilance, EVWeb, XEVMPD, EVDAS, CTIS and PRAC.
Get deep understanding about benefit risk evaluation.
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Understand aRMMs, DHCP communications and how to do them.
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Learn about PV inspections and audits.
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Understand what Artificial Intelligence would mean in Pharmacovigilance.
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Send your questions in advance to the speakers.
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Solve your doubts in the proper forum.
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Improve your PV operations and compliance.
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Get to know what you are doing properly and what you need to improve.
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Feel more confident in your pharmacovigilance day-to-day.
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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
AGENDA
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Day 1: 27-May-2024 |
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9:00-9:15 |
Welcome and registration |
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9:15-9:45 |
Introduction and overview of the agenda – Keynote: GVP, impact of new technologies and AI in PV Jose A. Ayala Ortiz |
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9:45-10:30 |
PV systems best practices – beyond the guidelines Ricardo Andrade |
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10:30-11:00 |
COFFEE BREAK |
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11:00-11:45 |
Artificial Intelligence in Pharmacovigilance, QPPV perspective Julia Appelskog |
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11:45-12:30 |
Artificial Intelligence in Pharmacovigilance, practical considerations and examples Jan Petracek |
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12:30-13:00 |
ROUNDTABLE Ricardo Andrade, Julia Appelskog, Jan Petracek and Jose A. Ayala Ortiz (moderator) The roundtable will allow participants to make questions on the topics covered in the sessions |
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13:00-14:00 |
LUNCH BREAK |
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14:00-14:45 |
EudraVigilance, EMA, XEVMPD, EVDAS, Signal Management, PRAC, CTIS Updates Calin Lungu |
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14:45-15:30 |
Pharmacovigilance in the UK post BREXIT Elspeth McIntosh Elspeth will update us on the PV landscape post-BREXIT, including the most recent information from MHRA |
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15:30-16:00 |
COFFEE BREAK |
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16:00-16:45 |
PSMF & Global PSMF María José Reneses |
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16:45-17:15 |
ROUNDTABLE Calin Lungu, Elspeth McIntosh, María José Reneses and Jose A. Ayala Ortiz (moderator) The roundtable will allow participants to make questions on the topics covered in the sessions |
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Day 2: 28-May-2024 |
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9:00-9:45 |
Implementation of a new Safety database at Leo Pharma Pilar Carrero In this session, Pilar will share with us the experiences derived from the challenging project of the implementation of a new Safety database at Leo Pharma. |
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9:45-10:30 |
The QPPV role Elspeth McIntosh |
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10:30-10:45 |
COFFEE BREAK |
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10:45-12:15 |
Risk Management in Pharmacovigilance Jan Petracek |
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12:15-12:45 |
ROUNDTABLE Pilar Carrero, Elspeth McIntosh, Jan Petracek and Jose A. Ayala Ortiz (moderator) The roundtable will allow participants to make questions on the topics covered in the sessions |
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12:45-14:00 |
LUNCH BREAK |
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14:00-14:45 |
Pharmacovigilance Quality Management Systems Marta Rodríguez |
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14:45-15:30 |
GVP Inspections, considerations from the pharmaceutical industry Sofia Cavero |
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15:30-15:45 |
COFFEE BREAK |
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15:45-16:30 |
Pharmacovilance Audits Calin Lungu This presentation will provide learnings related to Pharmacovigilance Audits. Calin, as an expert auditor will share guidance considerations and practical experiences. |
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16:30-17:00 |
ROUNDTABLE Marta Rodríguez, Sofia Cavero, Calin Lungu and Emma Cebrian (moderator) The roundtable will allow participants to make questions on the topics covered in the sessions |
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17:00-17:15 |
Final note and closure |
(Agenda may be subject to changes)
Location
The training will take place next May 27th and 28th in Madrid, Spain. Join us at the Hotel Iberostar las Letras, 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.iberostar.com/es/hoteles/madrid/iberostar-las-letras-gran-via/
Watch the video of the 2022 edition. Don’t miss the 2024 edition!
Registration fees
Standard 2 days: 990€
Standard 1 day: 550€
Includes training and course material in digital format.
Participants that choose to attend the face-to-face option, will receive complementary refreshment breaks and lunches (limited seats!).
Online and interactive training sessions for the remote participants
Offers (non-cumulative, only the most beneficial one would apply):
Early Bird (Until 26th April): 15% discount on Standard fee
Reduced fee for SME: 20% discount on Standard fee
Register 2 individuals from the same company and receive a 20% discount from the standard fee.
Please also consult our special fees for University students/unemployed (upon presentation of documentation): info at trainingservices@pvpharm.com
Registration form
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PHARMACOVIGILANCE TRAINING
V Edition Madrid & Online 27-28 May 2024