Mary joined NDA as a Medical Advisor in 2001. With over 30 years’ experience in clinical development (medical oncology), market authorisation application strategies and pharmacovigilance.
Mary applies her experience to all phases of development, providing direction and guidance in optimizing dossiers, preparation for regulatory review, oral explanations, and the challenging questions that companies are faced with.
Key Areas Of Expertise
- Detailed knowledge of the European approval system including the European Medicines Agency (EMA).
- Hearings/Oral Explanation meetings with national authorities and EMEA
- Participation in mock Oral Explanation meetings as an ex-regulator
- Pre-submission meetings
- Clinical documentation requirements to support European Clinical Trial Applications (CTA) and Marketing Authorisation Applications (MAA)
- including assessment of non-clinical and clinical dossiers of Marketing Authorisation Applications for small chemical entities and recombinant biotherapeutics
- Review of draft response documents in MRP, DCP and CP
- Strategic and scientific/regulatory assistance in preparing Briefing documents, written responses to queries/lists of questions and meetings with Regulatory Authorities
- Design of clinical development plans:
- Scientific and strategic aspects
- Optimisation of clinical development plans, including risk management
- Evaluation and tackling of regulatory risks and hurdles
- Post-marketing (PM) authorisation activities including review of PMS study plans, review of PM safety experience
- Attendance as regulatory expert in medicinal product development milestone meetings and workshops
Before Joining The NDA Advisory Board
Mary was the Medical Director of Irish Medicines Board, Committee for Human Medicinal Products (previously CPMP) member, Ireland, later vice-chairperson; Chairperson, of CPMP Scientific Advice Review Group and the Ad Hoc Committee on Anti-Cancer Agents.
Recent Publications
