PHARMACOVIGILANCE IN CHILE
Experts in Consulting for the Pharmaceutical Industry and Clinical Research
28-year experience in Pharmacovigilance
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In Chile and the world there is a growing interest and need for medicines of biological origin (i.e. biotechnological products, vaccines, antivirals, antibiotics, others).
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These types of products have more regulatory obligations and requirements of Benefit-Risk evaluations than the most common drugs, however they all require Pharmacovigilance throughout their whole life cycle on the market .
Q.F. Ana María Piddo M.
Founder and CEO
SOLUTIONS
Design, implementation and maintenance of the Pharmacovigilance System
Training Programs in Pharmacovigilance
Preparation of documents required by the Regulatory Authority:
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Risk Management Plans (RMP)
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Periodic Safety Reports (PSUR)
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Description of Pharmacovigilance System
Audits and Preparation for Regulatory Authority Inspections
to ensure compliance with internal procedures and current legislation
Drafting of Procedures:
Standard Operating Procedures
Business Continuity Plans
Review of medical literature
to identify adverse drug reactions, ADRs
Medical translations
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Risk Management Plans
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Periodic Safety Reports
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Clinical Studies Protocols, Regulations
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Other type of medical documents
Training in:
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SVI system (Sistema de Vigilancia Integrada, ISP)
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Databases of Pharmacovigilance
Call Center Audit
Quality checks of Patient Programs records, from the Pharmacovigilance perspective.