General News
April 22, 2019
On Friday 12th April 2019, I had the opportunity to attend a seminar on good cellular therapy practices organized by the Spanish Ministry of Health and the Spanish Competent Authority, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) representing our consulting firm, Pharmity. Speakers from the Ministry of Health, AEMPS, […]
December 11, 2018
All adverse drug reactions (ADRs) that are both serious and unexpected (Suspected Unexpected Serious Adverse Reactions, SUSARs) are subject to expedited reporting. Since the main objective of pharmacovigilance is the identification of information that may affect the safety of patients, once a potential risk is noted, it must be communicated […]
September 26, 2018
Whether paper or eSource, investigators and sponsors need to ensure that there are adequate controls in place to preserve the confidentiality, integrity, and security of data. Electronic Health Records (EHR) systems need to be assessed by the Sponsor and/or CRO for compliance with regulatory requirements before investigator sites activation, but […]
August 27, 2018
Maintaining an audit trail is a regulatory compliance requirement, but what makes a good audit trail that is effective and complies with regulations? This article will explain what and audit trail is, what the applicable regulations are and the main aspects to consider when implementing an audit trail to contribute […]