Product – ICRC-WEYER GmbH
Contact Supplier: ICRC-WEYER GmbH
Supplier Product: Pharmacovigilance Services
Address: Boelschestrasse 2, D-12587 Berlin, Germany
Tel: +49 (30) 40 39 37 – 0
Fax: +49 (30) 40 39 37 – 18
ICRC-Weyer services cover pharmacovigilance in the pre and post marketing settings. In order to comply with a wide variety of regulatory requirements, ICRC-Weyer provides highly qualified and experienced personnel and thereby ensures standardisation and safety of the pharmacovigilance processes. Our pharmacovigilance team offers you full or partial service solutions.
In compliance to extensive reporting requirements starting from July 2012, ICRC-Weyer uses the eDrug Safety Database VigilanceOne. This system is compliant with ICH-E2B and supports the E2B data exchange via the Eudravigilance gateway. It also offers exchange formats that guarantee efficient data exchange between VigilanceOne and external receivers and regulatory authorities.
Our pharmacovigilance services include:
• Set-up and maintenance of validated safety databases
• 24/7 SAE stand-by-service
• Development of Safety Monitoring Plan
• Data entry and SUSAR/ICSR-Handling
• SAE/AE reporting
• Expedited reporting
• Development Safety Update Reports (DSURs)
• Periodic safety update reports (PSURs)
• Risk Management Plans (RMPs)
• Monthly line listings
• Medical safety reviews
For more information or to discuss pharmacovigilance services please contact us directly.