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April 22, 2019

Advanced Therapy Investigational Medicinal Product (ATIMP) Trials

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, […]
January 4, 2019

Development Goals. The Right Way to Keep Your Team Engaged!

How many articles or blog posts have you read lately regarding leadership, how to keep company’s employees happy and engaged? I can tell you that I have read loads and some of them are extremely good. You can see in social media how many likes they get and the hundred […]
December 11, 2018

Safety reporting to investigators (SUSARs): Mistakes you will never make again

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

How to Assess an Electronic Health Records (EHR) System for Clinical Research

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

Data Integrity – How To Implement An Effective Audit Trail

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 […]