One of the major obstacles to the access of health products, including vaccines, is the delay in their approval by regulatory authorities after submission of product applications by manufacturers. Poor quality submissions and inadequate data provided by manufacturers have been identified as main obstacles by regulatory authorities. This workshop, organized by the WHO Local Production and Assistance Unit, with financial support from the Bill & Melinda Gates Foundation (BMGF), aims to enhance the understanding and promote best practices amongst manufacturers, particularly in low- and middle-income countries, on quality requirements for vaccines as described in the guidelines of WHO and other regulatory authorities for prequalification and licensing purposes.
This workshop is taking place virtually from 28 June to 1st July 2022, and is intended for vaccine manufacturers, developers and manufacturers intending to produce vaccines, and will benefit technical personnel working in Production, Quality Control, Quality Assurance and Regulatory Affairs. National Regulatory Authorities and officials from related government ministries are welcome to participate.
Objectives:
1. Building participants’ understanding of the current quality requirements as described in WHO guidelines and relevant guidelines of other regulatory bodies
2. Formatting of regulatory documentation
3. Discussing approaches to formulating responses to assessment reports through a case study
4. Reviewing challenges and constraints faced by new manufacturers and exploring approaches to address them Intended.
For more information, please contact the LPA Unit Secretariat at: localproduction@who.int