DDReg Pharma

Pharmacovigilance services in Singapore

The Health Sciences Authority (HSA) and Pharmacovigilance Advisory Committee (PVAC) oversee the pharmacovigilance system in Singapore. PVAC is a team of experts from the fields of medicine, pharmacy, pharmacology, and forensic sciences specially appointed to assess the effects of adverse drug events and provides guidance for the regulatory action related to the enhancement of the safety of the products. Reporting of all serious events is mandatory for pharmaceutical companies by filling out the CIOMS I form and submitting it via online reporting or to the Vigilance and Compliance branch. Consumers are encouraged to report adverse events through their healthcare professionals. The HSA encourages healthcare professionals to report any adverse drug reactions related to the health products online or in manual forms for all health products except vaccines, vaccines, and medical device forms.
As a leading global contender, DDReg understand the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Singapore that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
PV Services
PV Audit & Compliance
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