FREE WEBINAR | Pharmacovigilance Databases: How to succeed when facing an inspection? 

Miriam Alvarez, Drug Safety Manager at Asphalion, will review in this webinar the essential elements to take into consideration, including QMS, management of computerized systems, access control; data protection, etc. Furthermore, she will go over the relevant documentation to keep in mind, and will offer tips on which are the most common findings in this type of audits.

Miriam Alvarez, Drug Safety Manager at Asphalion, will review in this webinar the essential elements to take into consideration, including QMS, management of computerized systems, access control; data protection, etc. Furthermore, she will go over the relevant documentation to keep in mind, and will offer tips on which are the most common findings in this type of audits.
August 24, 2023

September 26, 2023             3:00- 3:30 p.m. CEST

Over the past years, assessment of drug safety has been radically reshaped by the availability of safety databases, which are the global repository of thousands of data, and a critical element of pharmacovigilance work. As a key tool for the evaluation of safety data, it is necessary that safety databases undergo periodic evaluations to guarantee their correct operation, ensuring compliance with the Pharmacovigilance relevant regulatory requirements and data security.

Join Asphalion expert Miriam Álvarez Fiz in this webinar to find out what you should take into account when facing an audit of your database. She will go over:

 

  • Legal framework/requirements of PV databases
  • Definition of how an evaluation is conducted
  • Tips on how to overcome common findings

 

Registrations are open. You can register here:

https://bit.ly/3QXsRGx

For further information you can contact us at: [email protected]

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