Attestato di partecipazione
Introduzione
Pharmacovigilance is a discipline aimed at continuously assessing all information relating to the safety of medicinal products, both in development and on the market, and at ensuring that the risk-benefit ratio remains favourable.
This needs highly trained staff to ascertain both compliance as well as quality, whether in case reporting, aggregate reports, signaling, or in (re-)writing a Risk Management Plan.
The aim of the masterclass is to provide an understanding of the aims and objectives of pharmacovigilance, to examine the legislation in force, and to interpret and manage information on the safety of medicinal products. Thereby ensuring that participants can acquire the necessary tools to deal with day-to-day operations on an adequate knowledge basis.
Docente/i
Dr. med. Renald Hennig
In addition to having more than 20 years of experience in Pharmacovigilance, he very much enjoys sharing and training. He is medically qualified as well as an MBA. His PV experience includes responsibilities as the QPPV for major pharmaceutical companies and significant auditing experiences. A quote he likes (from Sir Liam Donaldson): ‘To err is human, to cover up is unforgivable, and to fail to learn is inexcusable.’
Dr. med. Susanne Kienzle-Horn
After completion of her medical degree, she added a computer science degree and a coaching certificate. Initial positions as a medical project manager were followed by more and more senior (Medical Director) and safety related functions, until she decided to become independent and founded SCRATCH in 2001. One of her favorite statements: ‘To listen is a silent yet fundamental statement.’
Dr. rer. nat. Nicole Niemeier-Siegl
She studied biology in Karlsruhe and in 2009 completed her doctoral thesis there at the Research Centre in the Helmholtz Association. After working as a scientific postdoc, she switched to pharmaceutical consulting, including training activities for pharmacy staff.
Since 2015, she has been working as Scientific Manager PV for SCRATCH Pharmacovigilance – in all areas of PV, with a focus on clinical trials and joy in imparting knowledge.
Magnus Lühring
He got in touch with the world of PV as the first permanent employee at SCRATCH Pharmacovigilance in Sep 2005, directly after having completed his medical documentalist education.
His main area of work comprises ICSR processing in several different databases, incl. submission to authorities, handling of multiple EudraVigilance related tools (incl. registration / maintenance of companies and users), as well as holding PV seminars and webinars. He is also involved in trainee education. Since 2009 he is a Certified MedDRA Coder, since 2014 a TÜV-certified Pharmacovigilance Manager.
Dates TBD
After the registration, you will receive all details about the connection.
The Masterclass will be confirmed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Limited number: maximum 15 attendees.
The certificate of attendance of the whole training will be delivered to the participants who will attend the 80% of the training course at least.
Super Early Bird: € 2.980,00*
Early Bird: € 3.190,00*
Ordinary: € 3.980,00*
Freelance – Academy – Public Administration**: € 2.230,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials for each training and attendance certificate that will be sent after the complete masterclass via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il percorso formativo
Online training path on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before each module.