Establishing of pharmacovigilance system:

• The system will be established exclusively for your situation.
• We have an experienced Qualified Person for Pharmacovigilance (QPPV).
• We have access to EudraVigilance database (processing of ICSRs, submission of product information).
• Literature screening.
• Staff training.
• Preparation of local standard operating procedures.
• Communication with competent authorities.

• Support during audits.

Applies to:

Acting as Local Safety Contacts. This includes:

• Preparation of local Standard Operation Procedures (SOPs);
• Local database for safety information;
• Signal detection;
• Local literature screening;
• Trainings;
• Submission of relevant documentation (reports, PSURs, etc.);
• Communication with competent authorities;
• Support with the case on the national level (follow-up, translation, local database, etc.);

• Other related tasks.

Applies to:

Trainings

• We are ready to train you and your staff, which is an easy way to be in line with legislation and to keep you up to date.

These can be in-house trainings or distance learning.