Why You Need to Take This Training Course?
This Course will provide you with the following three Benefits:
1- Enhanced Expertise in Veterinary Immunological Data Dossiers: This training equips regulatory personnel with the specialized knowledge and skills needed to effectively review and evaluate veterinary immunological data dossiers.
- Participants gain a deeper understanding of the specific requirements and regulations governing veterinary immunological products.
- They learn how to interpret complex scientific data related to immunogenicity, safety, and efficacy, crucial for thorough dossier assessment.
- By focusing on veterinary immunology specifically, the course ensures regulatory personnel are up-to-date on the latest advancements and considerations in this field.
2- Improved Efficiency and Streamlined Review Process: By understanding the structure and content of veterinary immunological data dossiers, regulatory personnel can review them more efficiently and effectively.
- The training familiarizes participants with the expected format and organization of the dossier, allowing them to locate relevant information quickly.
- They learn to identify potential issues or missing data, leading to a more focused and streamlined review process.
- Improved efficiency can expedite regulatory approvals for new veterinary immunological products, ultimately benefiting animal health.
3- Stronger Regulatory Decision-Making: The training equips regulatory personnel with the skills to make informed and well-supported decisions regarding the approval of veterinary immunological products.
- Participants develop critical thinking skills to analyze complex data and assess potential risks and benefits associated with the product.
- The training fosters a deeper understanding of the scientific rationale behind the data presented in the dossier, leading to more confident and science-based regulatory decisions.
What you'll learn
- Participant will have general introduction on the overall structure of the Veterinary dossier data information requirements
- Participant will understand how to fill & review part one of the Vet file based on ICH guidelines (ex. using SFDA & Gulf Requirements) with examples
- Participant will be able to compile and/or evaluate registration part two (Quality Documentation) of the Vet file to insure submission without deficiencies. This will be supported with examples
- Participant will understand the different studies (safety and residues tests , preclinical and clinical trials) needed to complete part three and four of the file and the rational behind them
Instructor: Dr. Samer Sowidan
This 15-hour Training Course is Equivalent to 13 Continuing Professional Development (CPD) hours.
- Duration: 15 Hrs. Two Days
- Time: 9.00 am-4.30 pm
- Prerequisite for this course: None
- Language: English
- Level: Management or any one interested
- Classroom or Vitual Training
- Price US $ 495
- Certified and Accredited Certificate
- Discount available for companies who send three or more participants
- Seats for this course: 12
- Virtual through google meet
- Classroom course at Upbeat office, hotel or at the customer premises
