After the successful first edition, PVpharm is organizing a face-to-face training in Madrid on 9-10 May 2019. Join us to learn about the latest updates! This training is targeted to Pharmacovigilance professionals. The objective is to provide professional knowledge on this area.
Register here or send us an email to info@pvpharm.com
How are you dealing with new PV requirements since November 2017? Are you sure you and your company are in compliance with new regulatory obligations?
This year we will focus on Audits, Inspections, the QPPV role and, of course, Eudravigilance and Signal Detection. We will also cover the new GDPR from the perspective of Pharmacovigilance!
- EU-QPPV perspective
- Organizational aspects in Pharmacovigilance: the PV department
- Audits and Inspections in PV
- Auditing of the QPPV function
- Audit of PSURs and interfaces in the company
- Audit of computerised systems in Pharmacovigilance
- Data protection, GDPR in Pharmacovigilance
- EVDAS: Signal Detection in EudraVigilance
- EVDAS: medical evaluation
- Sources of information in pharmacovigilance
- Regulator perspective, international experiences
- Practical examples and activities
- Questions and answers and more…
COURSE OBJETIVES
This year we will focus on different areas, but always from the perspective of the QPPV. We will talk about how a PV department is organized, the role of the QPPV and how this function is audited. A Pharmacovigilance audit is a very important activity to carry out in a pharmaceutical company. Thanks to audits you can detect the risks existing in the system and set up priorities to ensure company regulations compliance and protection. Consequently, by auditing, the company avoids any inspection problem. Moreover, apart from the QPPV audit we will have the opportunity to learn about the audit of the process of PSUR production and submission and, also, about the auditing of computerised systems in Pharmacovigilance.
This pharmacovigilance training will also cover personal data protection issues in Pharmacovigilance, we will talk about the GDPR from a lawyer perspective.
We will also be talking about the latest updates in the use of EVDAS for signal detection in pharmacovigilance, with practical examples of medical evaluation in signal management, focussing also on the issues most frequently encountered.
Furthermore, our course will treat other different subjects such as the international context of pharmacovigilance, and sources of information in pharmacovigilance, in order to document signal detection, ICSRs, PSURs, Referrals and more, presenting practical situations which may impact on daily activities.
The course will be delivered by experienced trainers in the field who know the most critical aspects affecting PV employees firsthand. Throughout the training sessions, practical examples and frequently asked questions will be addressed through a rigorous and practical approach.
FACULTY
Mariano Madurga
Mariano Madurga is a pharmacist, with training in Public Health, Pharmacoepidemiology and Pharmacovigilance. The last 30 years have been dedicated to information on medicines, development of databases and pharmacovigilance systems, along with teaching and research. Since 1986 he has been an official of the Ministry of Health of Spain. In the AEMPS has developed and coordinated the Spanish Pharmacovigilance System (SEFV), unique model in the EU environment, until his retirement. His experience has served as a model for the network of PV in Central America, the FACEDRA system. He is currently a Pharmacovigilance and Expert Consultant for PAHO and Reviewer in the Signal Review Panel of UMC, WHO.
José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) has been working 15 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, 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.
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.
Maite Vazquez Calo is economist and lawyer, with training in Biotechnology and Pharma Law.
As partner, she leads DA Lawyers Life Science practice. The last 20 years she has been advising companies in pharma and bio industry in regulatory, contracts, corporate and compliance matters.
She is the secretary of the Board of the Spanish Biotechnology Association (ASEBIO) and legal advisor in the Pharma and Health group of the Bar Association of Madrd (ICAM)
Bachelor of Sciences in Pharmacy at the University of Barcelona. He is currently the EU-Qualified person responsible for pharmacovigilance (QPPV) at Ferrer Internacional, a Spanish private pharmaceutical company. He joined Ferrer in 2008, where he has gained experienced in different areas such as regulatory affairs and price and reimbursement, although his main focus has been in the pharmacovigilance field. He was appointed Deputy QPPV in 2009, and promoted to QPPV in 2013. He has been responsible for building a pharmacovigilance system for the company, not only at European level but also at worldwide level.
REASONS TO ATTEND
- Understanding of PV responsibilities of the MAH
- Role of the QPPV
- Auditing of the QPPV
- Help your company to be inspection-ready in PV
- Gain a robust understanding on new PV regulations
- Learn about the new GDPR in Pharmacovigilance
- Wise up about the implications that Brexit carries on
- Solve your doubts in the proper forum
- Improve your PV operations and compliance
- Get the newest and most rigorous information on EudraVigilance and EVDAS
- Improve your signal detection processes
- 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
Location
The training will take place next May 9th and 10th 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.
Registration form