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Isa Costa

Associate Director International Pharmacovigilance Operations at Johnson & Johnson

I am a graduate in Pharmaceutical Sciences from Lisbon University and I have recently concluded an Executive Program, Leading Pharma at Católica-Lisbon. I have 13 years of experience in the pharmaceutical industry, handling different responsibilities in Regulatory Affairs, Pharmacovigilance and Medical Information, and have been involved in many local and international projects and working groups related to my areas of expertise. Additionally, I am skilled in training, public speaking, epidemiology, leadership, negotiation. Areas related to patient safety, public and policy health and communication are a real interest to me. I am passionate for everything that can contribute to the safe use of medicines and all strategic solutions that help to preserve and promote the health and well-being of populations and communities. I’m keen on continuous creative learning, thus enabling the use of all the tools necessary to achieve correctly my professional and personal objectives.

 

Isa Costa

Associate Director International Pharmacovigilance Operations

Johnson & Johnson

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8:05 - 8:45 AM

Friday 7 June

PV Compliance Governance Model - "A Competitive Driver For a Healthy PV System"

PV Compliance must be viewed as a source of competitive advantage and customer differentiation and not simply as cost investment and operational work. With the fast growing complexity of the pharmacovigilance landscape, there is a need for companies to rethink their working model to identify issues and risks earlier in time and have a robust communication and escalation mechanism with clear roles and responsibilities sustained by robust processes that enable them to proactively and successfully tackle those focused areas and prevent non-compliance. Having a robust and well-thought PV compliance governance model composed by tactical and practical solutions and tools are fundamentals to be inspection ready at all times and ensure a healthy local PV system mainly in a continuous changing Era.

 

Isa Costa

Associate Director International Pharmacovigilance Operations

Johnson & Johnson

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