This is UK competent authority responsible for regulating medicines and medical devices and to authorize their marketing in UK ensuring quality, safety and efficacy. Following is a brief description of my technical attributes:
- Expert in regulatory affair, strategy and planning for marketing authorization of medicines.
- Assessment and evaluation of marketing authorization dossiers with respect to quality (CMC) ensuring compliance with the requirements of the relevant Directives and guidelines. In this aspect different dosage forms including sterile and modified release preparations among others were reviewed and assessed. Followings are some of the areas that are of special int
- Expert in Vitamin D3 technical and quality standards covering the API and finished products. In this aspect most if not all applications that have been submitted to the agency were assigned to me for assessment. So far more than 20 applications of different dosage forms and strengths using different types of API have been successfully assessed.
- Highly specialized in the field of formulation development and dissolution performance linked to bioavailability and conditions for biowaiver. In this aspect a number of specialized presentations and illustrations were given within the agency to improve on guideline understanding.
- Very deep knowledge in HPLC pharmaceutical analysis and method validation to comply with the current technical and regulatory requirements.
- Very deep knowledge in stability studies, and kinetics ensuring compliance with the requirements and recommendations of guidelines.
- Considerable knowledge in bioequivalence studies and guideline requirements. In this aspect a number of bioequivalence studies submitted have been reviewed and assessed.
- Considerable knowledge in manufacturing process validation with regard to protocols, implementation and analysis.
- Good knowledge in QbD and risk assessment with regard to formulation development and manufacturing process.
- Lead Pharmaceutical assessor in a number of European marketing authorization applications submitted either centrally, decentralized (DCP) or via mutual recognition (MRP) procedures.
- Contributing to CHM and EAG.
- Liaising with the other European competent authorities to ensure progress and conclusion of the application within the legislative time frame.
- Mentoring fellow new assessors leading to their accreditation.
- Representing the licensing division in a number of cross the agency meetings to share views and reaching decisions about issues that are of common interest.
- Providing scientific advice to the industry and discussing their need to ensure compliance with the current regulatory and scientific requirements.
- Assessment of bioequivalence studies submitted in support of marketing authorisation of generic medicinal products compared to brand.
- Assisting the manager in the preparation of answers to official correspondence for requests made from the stake holders as well as answering MAH queries regarding dossier submission and regulatory requirements. During work in MHRA a number of break-through issues with regard to controlling the quality of the API and finished product and relevance to the current regulatory requirements have been made. Among those
- Effect of Surface Area to Volume ratio of Immediate Release (IR) multiple- strengths product formulations on their dissolution behavior and compliance with the regulatory requirements for biowaiver acceptance criteria. In this aspect a number of presentations to the assessors of the agency were made to explain this factor and its possible impact on the dissolution behaviour of multiple strength products and how biowaiver can be applied.
- Effect of vehicle on the bioavailability of API from oral solution. In this aspect a presentation to the assessors of the agency has been presented explaining the main points given in the current guidance covering this topic and limitations affecting its wider applications. Special cases that might not be suitably governed by the current guidance with possible implication on the currently approved formulation have been highlighted.
- Applicability and level of the relevant GMP standard required for governing the manufacturing steps of mixing pure API with other excipients to manufacture ready-made API mixture termed (APIX). Special case for Vitamin D3 and legal ramification in considering APIX as a variant of API rather than as an intermediate product used for the manufacture of the finished product with significant impact on the number of applications submitted to the agency has to be carefully considered. QWP has been involved to reach final decision.
- Requirements for a specific test to determine the raft forming effect of alginic acid containing formulation to comply with acceptance criteria linked to the clinical effect indicated. The method of assay of alginic acid used is based on destructing the structure of the acid into a number of fragments and hence cannot be recommended for this purpose.