Full Name
Dr Fitra Yovita Delviona
Hospital/Organisation/Company
Indonesian FDA
Speaker Bio
Fitra is a Doctor of Veterinary Medicine (DVM) specializing in the dual areas of biological product quality assurance and laboratory animal welfare. Currently serves at the National Control Laboratory (NCL) within the Indonesian Food and Drug Authority (Badan POM)
Core Expertise and Responsibilities
As a key member of the NCL team, she works in uniquely positioned at the intersection of regulatory compliance and scientific modernization. Key responsibilities include:
- Lot Release Evaluation: Performing critical lot release evaluation for both domestic and imported biological products, with direct experience in vaccine safety testing.
- Attending Veterinarian & 3R team: Serving as the Attending Veterinarian responsible for the management and welfare of the animal laboratory facility at the Indonesian FDA. This crucial role provides an authoritative perspective on the implementation and advancement of the 3Rs (Replacement, Reduction, and Refinement) principles.
- Method Development & Validation: Specializing in the development and validation of analytical methods, she proficient in both in vivo and in vitro laboratory techniques, with a strong focus on transitioning to modern, non-animal quality control schemes.
Professional Background and Focus
She earned the Bachelor and Doctor of Veterinary Medicine (DVM) degrees from the Faculty of Veterinary Medicine, IPB University. This foundation is complemented by certification as a Certified Laboratory Animal Practitioner (Cert.LAP) from the BNSP of Indonesia.
With five years of experience in medical device testing based on ISO 10993 (including systemic toxicity, pyrogen, bacterial endotoxin, and skin irritation), this expertise is now broadening toward complex biopharmaceutical products, such as biosimilars, blood products, and cell therapies. She maintains active membership in key professional organizations, including the Indonesian Veterinary Medical Association (PDHI), the Indonesian Association for Laboratory Animal Science (IALAS), and the Indonesian Laboratory Animal Veterinarians Association (ILAVA), reflecting a strong commitment to advancing the development of laboratory animal facilities and scientific standards in Indonesia.
Core Expertise and Responsibilities
As a key member of the NCL team, she works in uniquely positioned at the intersection of regulatory compliance and scientific modernization. Key responsibilities include:
- Lot Release Evaluation: Performing critical lot release evaluation for both domestic and imported biological products, with direct experience in vaccine safety testing.
- Attending Veterinarian & 3R team: Serving as the Attending Veterinarian responsible for the management and welfare of the animal laboratory facility at the Indonesian FDA. This crucial role provides an authoritative perspective on the implementation and advancement of the 3Rs (Replacement, Reduction, and Refinement) principles.
- Method Development & Validation: Specializing in the development and validation of analytical methods, she proficient in both in vivo and in vitro laboratory techniques, with a strong focus on transitioning to modern, non-animal quality control schemes.
Professional Background and Focus
She earned the Bachelor and Doctor of Veterinary Medicine (DVM) degrees from the Faculty of Veterinary Medicine, IPB University. This foundation is complemented by certification as a Certified Laboratory Animal Practitioner (Cert.LAP) from the BNSP of Indonesia.
With five years of experience in medical device testing based on ISO 10993 (including systemic toxicity, pyrogen, bacterial endotoxin, and skin irritation), this expertise is now broadening toward complex biopharmaceutical products, such as biosimilars, blood products, and cell therapies. She maintains active membership in key professional organizations, including the Indonesian Veterinary Medical Association (PDHI), the Indonesian Association for Laboratory Animal Science (IALAS), and the Indonesian Laboratory Animal Veterinarians Association (ILAVA), reflecting a strong commitment to advancing the development of laboratory animal facilities and scientific standards in Indonesia.
