1. Strategic Planning and Project Management
- Formulating product ideas that address unmet medical needs in accordance with regulatory requirements
- Drafting an overall regulatory strategy for medicinal products, combined products and medical devices to facilitate a quick and effective approval process
- Coordinating, monitoring and following up of project goals and timelines
- Support in seeking contract manufacturers and CROs (clinical research organizations)
2. Preclinical Development
- Assisting in the design of optimal pharmacology/toxicology studies specific to a particular product and in accordance with relevant regulatory guidance
3. Clinical and Medical Development
- Assisting in the design of different phases of clinical trials (phase I to IV)
- Preparing the IMPD (investigational medicinal product dossier), clinical protocol, investigational brochure, etc...
- Compiling and submitting clinical trial applications (CTAs) to competent authorities (Ethic Committee, PEI, BfArM)
- Compiling and submitting hospital exemption applications for Advanced Therapy medicinal Products (ATMPs)
- Supervising the management of ongoing clinical trials
- Developing a systematic approach to benefit-risk assessment of new medicinal products
4. Interaction with Regulatory Authorities
- Establishing a network of contacts with authorities for obtaining rapid responses to informal queries
- Planning of scientific advice meetings with national competent authorities and/or EMA
- Preparing the briefing documentation including list of questions, project position and background information
- Participating in the meetings, preparing slide presentations, submitting meeting minutes and ensuring their approval by the authorities
5. Micro-Costing and Economic Evaluation
- Employing micro costing methodology in the cost assessment of individual products to evaluate their cost-benefit effectiveness
