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Healthcare Products Surveillance

 

WiseHS directs advisory services in the area of surveillance of medicines for human use, medical devices, and Cosmetics & Body Care.

Pharmacovigilance

- Research in national and international literature related to drug safety;
- Adverse Drug Reaction (ADR) Notification;
- Preparation of Periodic Safety Update Reports (PSURs)
- Preparation and Review of Risk Management Plan
- Signal Detection

Medical Device Surveillance

- Support in the monitoring and supervision of the Medical Device in the market, within the scope of the National Medical Device Surveillance System.
- Research in national and international literature related to medical device safety;
- Notification of incidents;
- Preparation and Review of Periodic Safety Update Reports (PSURs)
- Preparation and Review of the Post-Marketing Monitoring Plan
- Preparation and Review of the Post-Marketing Clinical Follow-up Plan;
- Preparation and Review of Risk Management Plan
- Preparation of Clinical Evaluation Reports (CERs)
- Preparation and Review of Risk Management Plan
- Signal Detection

Cosmetovigilance

- Support in the monitoring and supervision of cosmetic and body care products placed on the market.
- Notification of undesirable effects of cosmetic products and obtaining additional information;
- Research in national and international literature related to the safety of cosmetics and body care products.