(Coming soon) 

 

  • Pre-marketing (clinical trials) & Post-marketing

 

Local QPPV in Italy EU QPPV and / or "Deputy QPPV" with service back-up 24 hours / 7 days, Monitoring Literature at the portal EMA, Bibliographic Research (Worldwide and / or Local)
Eudravigilance management on behalf of the MaHs as qualified Applicant, Case management in Eudravigilance
Preparation and review of PSURs (Periodic Safety Updated Reports)
Preparation / implementation of Standard Operating Procedures (SOPs)
Management of RNF (Pharmacovigilance National Network) in Italy
Management of ADR (Premises, from Research in Literature, non-EU)
Renting Database validated
Audit / Assessment Pharmacovigilance according to GVP
Database management and processing cases
Training of company personnel on pharmacovigilance obligations in accordance with applicable regulations
Preparation CCSI (Company Core Safety Information) or SmPC (Summary of Product Characteristics)
Preparation and Assessment of Risk Management Plan in accordance with GVP
Market surveillance for Medical Devices, Cosmetics, Dietary Supplements and Food for special medical purpose

 

NextraResearch is a micro enterprise, qualified by the SME Register - European Medicine Agency (EMA)

(https://fmapps.emea.europa.eu/SME/search_results2.php?CompanyName=nextraresearch&CompanyActivity=&Country=&search_submit=Search )

 

 

Enhancement of EudraVigilance (new)

On 22 November 2017, EMA launched a new and improved version of EudraVigilance(human). The new system has enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders. (*)

 

*from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000679.jsp

 

NEXTRARESEARCH SRL

Registered Office: Via Lorenzo Respighi, 7 - 00197 - Roma - Italy //  Ph.  (+39) 02 89950695 - Fax (+39) 06 92932362 - Fiscal Code/VAT nr. 14033291007

Contacts: regulatory@nextraresearch.eu -  info@nextraresearch.eu - nextraresearch@pec.it