Senior Pharmaceutical Assessor – Medicine and Healthcare Regulatory Agency (MHRA) June 2005 – January 2016 London, UK

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 interest
    • 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 are:
    • 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 behavior 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.

Technical Director – Hayat Pharmaceutical Industry Amman, Jordan (October 1999 – May 2001)

This is a privately owned pharmaceutical manufacturing company with a number of production lines including solid dosage form, liquid, semi-solid and suppositories, with 80 registered products. Internationally, the company is GMP compliant and moving towards registering some of its products within EU. 

  • Strategic Planning of the Division’s different departments with regard to activities and projects to include R&D Dept, Regulatory Affair unit, Production Dept, and Engineering Dept.
  • Approval of validation master plan and subsequent implementation with regard to company’s instruments, production machinery, and facility’s manufacturing environment.
  • Representing the company in a joint project between Jordan and EU in order to prepare and upgrade the Jordanian pharmaceutical manufacturing companies to comply with the EU GMP standard, as a first step towards registering the Jordanian medicinal products in EU.
  • Head of product dosage form design & development committee.
  • Drawing the company’s regulatory affair strategic plan and follow-up.
  • Approving the bioequivalence study protocol to be undertaken by CRO to comply with the international regulatory requirements.
  • Close follow-up with regard to development in rules and regulations as issued by MHRA and EMA. Relevance of these new rules and regulations to the company’s current activities and methodologies is judged and determined.
  • Acting as an expert to write up the Quality Overall Summary (QOS) of the CTD dossier. Recruiting qualified technical personnel and subsequent appraisal of performance.
  • Representing the company in a number of high level meetings that are of direct interest to the company.
  • Giving presentations about the company, research projects and manufacturing activities to high level delegates and executives visiting the site.
  • Recruiting qualified technical personnel and subsequent appraisal of performance.

Pharmaceutical Consultant – Arab Company for Drug Industries and Medical Appliances (ACIDMA) Amman, Jordan. (Jan 1999- Sept 1999)

This is a pan-Arab share holding company with the objectives to set up a strategy for the drug industries and medical appliances. This is achieved by conducting feasibility and technical studies of projects and subscribes along with the Arab governments and other parties once the project is realized.

  • Project management and action plan to establish “Bioequivalence Research Centre” in Amman, Jordan.
  • Reviewing the centre’s laboratories design, layout and furniture making sure of compliance with the requirements.
  • Reviewing and assessing instruments specifications, analyzing vendor’s offers and final selection to suit the centre’s specialized work.
  • Recruiting technical staff with the required skill and experience.
  • Approval and implementing relevant Quality Assurance protocols and SOPs.

Pharmaceutical Consultant – McGaw Biomed Auckland, New Zealand. (July 1998- January 1999)

This is a pharmaceutical manufacturing company, owned by an international American firm McGaw. It’s mainly concerned in manufacturing parenteral dosage forms. It has a number of sterile manufacturing units, whereby full GMP rules are implemented. 

  • Documentation of the product’s pharmacological, toxicological and clinical studies.
  • Acted as an expert in assessing the product’s development as well as the pharmacological and toxicological part of the dossier.
  • Tabulating the study report in the required manner.

New Product Development & Regulatory Affairs Departments Manager – Pharma-International Amman, Jordan. (March 1994 – September 1996)

This is a privately owned pharmaceutical manufacturing company, the manufacturing site of which is composed of two large buildings, the non-cephalosporin main building and cephalosporin building.

  • Head of dosage forms design and development committee.
  • Directly accountable for new product development which resulted in a number of products ready for scale up and pilot production.
  • Drawing protocol for methods of analysis development and validation.
  • Designing stability study protocol and approval of product master formula.
  • Reviewing and approval of the CMC sections of the marketing authorization dossier.

Pharma-International Manufacturing Plant. Amman, Jordan

Co-managed construction and successful operation of a $40 million new pharmaceutical manufacturing company. Responsibilities include:

  • Direct reporting to the EB about the progress of the project and level of achievement in line with the approved plan.
  • Reviewing the basic conceptual design of the project ensuring GMP compliance.
  • Head of machinery selection committee.
  • Establishing a new product development department with fully equipped laboratories.
  • Recruitment of technical staff, training and appraisal.

Hayat Pharmaceutical Industry & EU Cooperation Project

  • Technical director to represent HPI in a joint project between Jordan and EU in order to prepare and upgrade the Jordanian pharmaceutical manufacturing companies to comply with the European standards and levels including GMP, as a first step towards registering the Jordanian medicinal products in EU.
  • Developed close collaborations with a number of specialised consulting firms in the UK developing knowledge in facilities and environmental validation as well as dossier preparation in accordance with the EU requirements.

ACIDMA – Bioequivalence Centre

Establishing a fully equipped bioequivalence research centre from approval of layout design and instruments specifications to setting up the necessary protocols.

Team leader 11/1983 – 09/1991

Managing 5 research scientists to carry out academic research projects and investigate bioequivalence performance for generic products.

Manager, New product development Dept. 06/1993 – 09/1996

Managing 15 people including 2 senior formulation scientists, 2 registration officers, 5 scientists of different disciplines as well as 2 senior technicians and a number of technicians.