Misha is a Regulatory Affairs Manager with over 4 years of experience in the preparation, submission and oversight of CTA applications over a wide range of therapeutic areas to Regulatory Agencies. She has in-depth knowledge of the Clinical Trial Regulation and is able to deliver and oversee projects to ensure that key timelines are met.
Value to clients
With a background in clinical pharmacy and a thorough understanding of the clinical trial Lifecyle, Misha is able to work effectively with scientific input and effective communication with clients.
- In depth knowledge of the clinical trials regulation and medical device regulation/directive
- Experienced in managing and executing complex phase I – IV CTAs across all therapeutic areas
- Proven ability/success in protocol and IMPD development
- Able to conceptualise and strategize key timelines and deliver on project milestones
After completing her MPharm at the University of Nottingham, Misha is currently reading a Masters in Public Health at the University of Liverpool.
After qualifying as a pharmacist Misha worked as a Sponsor Representative and Clinical Trial Manager at the University College London/University College London Hospitals Joint Research Office. Here she managed and had oversight of clinical trials of medicinal products and medical devices across all therapeutic areas, from grant applications to site initiation and close out. She has also been involved in exceptional use applications and derogation to the MHRA for in-vitro, single use medical devices.
Other things about Misha
- Keen interest in ATIMPs and GMO
- Keen interest in Post Marketing Regulatory Processes
- Has hands on monitoring experience at site level
- Experienced in Quality Management Systems
- Is a Chief Pharmaceutical Officer for England Global Health Fellow