Luciana Zeng

Mrs
Luciana
Zeng

University of Bonn
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Biography
- Doctor of Veterinary Medicine with 10 years of Animal Health Regulatory Affairs experience. - Regulatory Affairs in Boehringer Ingelheim and Zoetis. - Masters Degree in Drug Regulatory Affairs (M.D.R.A) in course in University of Bonn (Germany) - Interest in Vaccinology and Biological products. Doctor of Veterinary Medicine with 10 years of Regulatory Affairs experience in the pharmaceutical industry. Proven track record in managing regulatory submissions and compliance across Brazil, the UK, and EU. Submission strategies, planning and execution of variations, renewals, promotional materials, and marketing expansions. Writing and reviewing submission contents related to new registration requests, variations and answers to health authorities. Management of projects in Regulatory Information Management systems. Skilled in developing regulatory strategies and engaging with authorities to facilitate product approval. Strong communicator, adept at working with cross-functional teams to ensure product quality and safety. Experience in the CMC Regulatory framework. Knowledge of quality control, quality assurance, and GMP requirements. Good familiarity with pharmaceutical research and development processes using scientific information. Solid experience with lifecycle maintenance (LCM) and gap analysis in regulatory assessments of pharmaceutical and biological products. Identification and mitigation of risks associated with regulatory procedures and activities.
Research interests
- Vaccinology - Monoclonal Antibodies - Biological products
Discipline
Challenge study design Clinical trials – efficacy Clinical trials – safety Epidemiology Ethics Immunology – B-cells Immunology – T-cells Immunology – innate Parasitology Quality assurance Registration Regulation Safety evaluation Virology
Host species
Cats Cattle Dogs Horses Pigs Poultry Small ruminants Zoonoses
Pathogen
Bacteria Viruses
Stage of vaccine development
Clinical trials Field trials Marketing Pre-clinical trials Vaccine delivery