Clinical Development & Regulatory Affairs

Our main task is to bring basic scientists and clinicians together in order to transform the research findings into practical applications. We support the BCRT researchers in navigating the EU- and FDA-regulatory pathways to speed up their product development process while ensuring compliance.

To enhance our mission, we have enforced long-term relationships with competent authorities and are officially acknowledged as an "Interested Party" by the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA).

Objectives

  • offer remedies for challenges that may confront scientists during the development process of their products
  • ensure timely and high quality project deliverables through developing tailored strategic plan for each individual project
  • establish a strong network of clinical scientists, research expertise, technologies and infrastructure under the umbrella of efficient project management
  • develop and manage national and international relationships with both academic and industry representatives
  • foster education by integrating the fundamentals of clinical and translational science within the framework of the BSRT graduate school program

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Services

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

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Team

  • Mohamed Abou-El-Enein
  • Dr. Barbara Pfüller

Prof. Dr. Mohamed Abou El-Enein
Head of Clinical Development Platform

Translational Research Specialist
Phone: +49 (0)30 450 539 594
Email: mohamed.abou-el-enein@charite.de

Yuliya Malakhava, MBA
Project Manager
Educational Program for Translational Scientist

Phone: +49 (0)30 450 539 605
Email: yuliya.malakhava@charite.de

Erma Salkic
Project Manager
Phone: +49 (0)30 450 539 606
Email: erma.salkic@charite.de

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Contact

Prof. Dr. Mohamed Abou-El-Enein

Head of Clinical Development Platform
Translational Research Specialist

Phone: +49 (0)30 450 539 594
Email: mohamed.abou-el-enein@charite.de