Rebecca has 20 years’ experience in the pharmaceutical industry, in Medical Affairs and Regulatory roles and leads the Early Access Program (EAP) Regulatory team. The team works very closely with the internal project team and Sponsor to provide the in-depth regulatory support that is essential for the set-up and management of an EAP.
Bionical Emas manages global EAPs on behalf of Sponsors, and as all countries have different and evolving regulations, rigorous regulatory surveillance and excellent information management are critical for efficient and informed decision-making. Working in such a diverse regulatory environment provides the team with a broad perspective and continually develops and challenges their strategic thinking skills, especially during the set-up of a program.
In many countries, the supply of an unlicensed medicine to a group of patients requires a Sponsor application to the relevant Competent Authority, typically including a protocol or treatment plan with defined eligibility criteria to standardise treatment in the specific group of patients. The EAP Regulatory Team regularly complete this activity on behalf of a Sponsor, preparing and submitting the dossier and conducting ongoing regulatory commitments.
Ultimately, Rebecca and the team strive to use their regulatory knowledge and expertise to support the timely access to innovative medicines to patients with a high unmet medical need, ensuring compliance and patient safety.
Leading the EAP Regulatory team allows Rebecca to use her passion for health science and extensive pharmaceutical experience for the benefit of patients and finds involvement in a medicine’s journey to commercialisation, very rewarding.