Welcome video for Regulatory Affair Track

[Audio] Regulatory Affairs plays a crucial role in ensuring that pharmaceuticals are safe for human consumption and meet the required standards for quality and efficacy. This involves a range of activities including compliance with regulations, conducting clinical trials, and managing product lifecycles. Effective regulatory affairs can help companies achieve their business objectives by reducing costs, improving efficiency, and increasing market share. In addition, regulatory affairs professionals often have to navigate complex regulatory environments, making them highly sought-after skills in the industry..

[Audio] Dr. Mamdouh Mostafa is the Viral Laboratory Manager at the Egyptian Drug Authority. He has extensive experience in regulating and controlling biological products, specifically viral vaccines and immunoglobulins. During his 17 years of service in Egypt's regulatory system, he has gained expertise in quality control, cGMP inspections, and implementing quality assurance measures. In his current role, he manages the viral control laboratory and oversees the quality of biological products. Dr. Mostafa has made significant contributions to the field, shaping the country's regulatory framework and promoting adherence to international standards. He is well-versed in the latest regulations and guidelines and ensures compliance and facilitates the approval process for pharmaceutical products. With his extensive knowledge and experience, Dr. Mostafa is an ideal instructor for this module, providing valuable insights into the complexities of regulatory affairs, vaccine and biopharmaceutical product development, clinical trials, and market surveillance..

[Audio] In this track, participants will explore six major areas related to Regulatory Affairs in Vaccine Manufacturing. These include an introduction to the global and African regulatory landscape, harmonization initiatives, new vaccine platforms, data integrity, and product lifecycle management. The course will also cover regulatory frameworks and guidelines such as Good Documentation Practices, GMP, GLP, Good Regulatory Practices, Good Reliance Practices, and evidence-based regulatory decision-making. Additionally, participants will learn about Clinical Trial Regulations, including GCP, ethical approvals, adverse event reporting, and compliant clinical study design. Other topics include Regulatory Submissions, Registration, and Labeling, which will cover CTD, DMF, BLA, registration procedures, labeling, variations, renewals, and accelerated access pathways. Participants will also gain an understanding of Lot Release and Market Control, which addresses principles of lot release, regulatory decision-making, market surveillance, and consumer protection. Lastly, Pharmacovigilance and Safety Monitoring will be discussed, which includes AEFI reporting, post-marketing surveillance, signal detection, and signal management..

[Audio] Dr. Mohamed El-Sayed Rashed is a highly-regarded expert in microbiology and immunology with more than 20 years of experience in regulating and ensuring the quality of biological products. In his role as a professor and laboratory evaluation administration manager, he has successfully led numerous teams in evaluating and testing vaccines and biological products to guarantee their safety, quality, and effectiveness. His extensive background also includes conducting cGMP inspections at both domestic and international vaccine and anti-sera manufacturing facilities, as well as participating in WHO inspections of laboratories. Dr. Mohamed's notable achievements include playing a significant role in achieving WHO Maturity Level 3 for the laboratory testing function during the benchmarking of the Egyptian Drug Authority in 2022. His expertise and leadership have greatly impacted the regulatory landscape not only in Egypt but also globally..

[Audio] Dr. Moushira Mamdouh Mostafa is an experienced instructor and the Viral Laboratory Manager at the Egyptian Drug Authority. She has extensive experience in regulating and controlling biological products, with a particular focus on viral vaccines and immunoglobulins. Dr. Moushira has been working within Egypt's regulatory framework since 2008 and currently oversees the viral control laboratory. Throughout her nearly two decades of work, she has made significant contributions to quality control, conducted cGMP inspections, and implemented quality management systems like ISO 9001, ISO 45001:2018, and ISO 17025. Additionally, she has played a crucial role in evaluating the quality of vaccines, including those seeking Emergency Use Authorization for COVID-19, and has provided technical assistance to local vaccine producers and controllers. Notably, her efforts have helped Egypt achieve World Health Organization (WHO) Maturity Level 3 status for its laboratory testing functions in the vaccine realm, and she is also a member of the USP Best Practices for mRNA Vaccines Expert Panel. Her expertise and dedication to the field of vaccine regulation and quality control are truly commendable..

[Audio] We have come to our final slide where I would like to introduce you to an accomplished professional in the field of regulatory affairs, Moushira Mamdouh. With 17 years of experience at the Egyptian regulatory authority, Moushira has established herself as a highly skilled specialist in the regulation and quality control of biological products, particularly in viral vaccines and immunoglobulins. Since 2008, she has been working at the National Organization for Research and Control of Biologics, currently holding the position of manager of the viral control laboratory. Moushira's expertise spans across various areas, including quality control, cGMP inspections, and the implementation of quality management systems such as ISO 9001, ISO 45001:2018, and ISO 17025. Her contributions also extend beyond national borders as she is a competent evaluator of chemical, manufacturing, and control files in vaccine development. Moushira played a vital role in evaluating the quality module of COVID-19 vaccines for Emergency Use Authorization (EUA) and provided technical support in the production and control of the Sinovac/VACSERA COVID-19 vaccine, a locally manufactured vaccine. Her career at the Egyptian Drug Authority has also given her valuable experience in regulatory systems strengthening and preparedness for WHO benchmarking. It is worth noting that her efforts contributed to Egypt receiving international recognition from WHO in 2022, specifically in the area of vaccines, as they were awarded the ML3 status for laboratory testing function. Additionally, Moushira is actively involved in various international collaborations, such as the AMRH Laboratory Twinning Program, where she was a speaker in both rounds held in Egypt and Senegal. She has also participated in the East African Community (EAC) Regional Centre of Excellence for Vaccines, Immunization, and Health Supply Chain Management (RCE-VIHSCM) and the sixth general meeting of the WHO-National Control Laboratory Network for Biologicals (WHO-NNB), both held in Egypt. As we conclude our presentation, it is evident that Moushira's contributions to the field of regulatory affairs are vast and impactful. She is also a member of various prestigious organizations, further solidifying her expertise in this field. We are honored to have her as part of our team and excited to see her continued success in the future. Thank you..