by In2Pharma | Dec 15, 2022 | News
Luxembourg There has been an update on: New instructions for the preparation and submission of additional risk minimisation material (aRMM) for evaluation and approval in Luxembourg: update contact detail adverse event reportingupdate address to send the printed...
by In2Pharma | Dec 19, 2018 | News
EMA EMA published the new good pharmacovigilance practice (GVP) Product- or Population-Specific Considerations IV containing specific considerations about pharmacovigilance for the pediatric population. It explains the importance of pediatric pharmacovigilance, the...
by In2Pharma | Sep 4, 2017 | News
EMA On 22 November 2017, a new and improved version of EudraVigilance will be launched by the European Medicines Agency (EMA). Users of this system, including marketing authorization holders and sponsors of clinical trials, should prepare themselves to ensure that...