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Postmarketing surveillance of
chemicals: organizations and databases
Workshop reporting Report 20170184
M. Bouwmeester et al. Postmarketing surveillance of chemicals:
organizations and databases
Workshop
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How to fill out post-marketing surveillance of

How to fill out post-marketing surveillance of
01
Gather all relevant information regarding the product being surveilled.
02
Understand the specific objectives and goals of the post-marketing surveillance.
03
Determine the appropriate methods and tools to be used for data collection.
04
Develop a standardized form or questionnaire to collect relevant data.
05
Train the individuals responsible for conducting the surveillance on proper data collection techniques.
06
Implement the surveillance by collecting data from various sources such as healthcare professionals, patients, and regulatory authorities.
07
Ensure the confidentiality and privacy of collected data.
08
Analyze the collected data to identify any patterns or potential safety concerns.
09
Evaluate the data analysis findings and make appropriate recommendations or actions.
10
Continuously monitor and review the surveillance process to improve its efficiency and effectiveness.
Who needs post-marketing surveillance of?
01
Pharmaceutical companies
02
Medical device manufacturers
03
Healthcare regulatory authorities
04
Healthcare professionals
05
Patients
06
Public health organizations
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What is post-marketing surveillance of?
Post-marketing surveillance is the process of monitoring the safety and effectiveness of a pharmaceutical product or medical device after it has been approved for marketing and is being used by patients.
Who is required to file post-marketing surveillance of?
The manufacturer or sponsor of the pharmaceutical product or medical device is required to file post-marketing surveillance.
How to fill out post-marketing surveillance of?
Post-marketing surveillance is filled out by collecting data from various sources, such as healthcare providers, patients, and clinical trials, and analyzing the information to assess the product's safety and effectiveness.
What is the purpose of post-marketing surveillance of?
The purpose of post-marketing surveillance is to detect any potential safety issues or new information about the product that was not known during the initial approval process.
What information must be reported on post-marketing surveillance of?
Information such as adverse events, patient outcomes, and any new data on the product's effectiveness must be reported on post-marketing surveillance.
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