Joemar Odquier

Achievement:

• Subject Matter Expert to the Training on Registration Process of Center for Drug Regulation and Research held on 2-3 October 2024 at the Vivere Hotel, Alabang, Muntinlupa City.
• Successfully completed the "Advance Coursed on Post-Approval Changes" online training course based on the WHO PAC guidelines on February 27, 2023.
• Successfully completed the "Essentials of Post-Approval Changes Online Training Course" based on the WHO PAC Guidelines on February 27, 2023.

Responsibilities:

• Reviewed and assessed Initial (Generic-Rx) Application for compliance with regulatory standards, ensuring thorough evaluation of data related to safety, efficacy, and quality.
• Manage Major and Minor Variations by evaluating proposed changes, analyzing their impact on product safety and compliance, and facilitating timely processing.
• Ensured adherence to local and international regulations, monitoring updates and providing guidance to stakeholders on regulatory requirements.
• Liaised with pharmaceutical companies and healthcare professionals to streamline application and variation processes, offering training on regulatory standards.
• Maintained accurate records of applications and variations, preparing detailed reports to support regulatory decision-making.

Achievement:

• Participated in the Center of Excellence of TFDA/RAPS Taiwan Chapter "2022 APEC Good Registration Management Regulatory Science Center of Excellence Workshop" on 29 August - 15 September 2022

Responsibilities:

• Manage Major and Minor Variations by evaluating proposed changes, analyzing their impact on product safety and compliance, and facilitating timely processing.
• Ensured adherence to local and international regulations, monitoring updates and providing guidance to stakeholders on regulatory requirements.
• Liaised with pharmaceutical companies and healthcare professionals to streamline application and variation processes, offering training on regulatory standards.
• Maintained accurate records of applications and variations, preparing detailed reports to support regulatory decision-making.

Responsibilities:

• Manage Major and Minor Variations by evaluating proposed changes, analyzing their impact on product safety and compliance, and facilitating timely processing.
• Liaised with pharmaceutical companies and healthcare professionals to streamline application and variation processes, offering training on regulatory standards.
• Maintained accurate records of applications and variations, preparing detailed reports to support regulatory decision-making.

Achievement:

• Participated in 3rd Joint Commission International's (JCI) global standards accreditation.

Responsibilities:

• Audit medications through the actual review of the patients chart, medication administration record and medication bin.
• Dispensed and counter-check the 24-hour supply/unit dose medications of the patients.
• Update the patient drug profile on a daily basis base on the review of patients chart.
• Stamp the reminder on collaborative notes on the 6th and 7th days of antibiotics as part of the antimicrobial stewardship program.