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Capacity Development

Fellowships for the Assessment of Medicinal Products

The GHPP PharmTrain2 Fellowships encompass two specialised programmes

I. The Clinical Fellowship focusing on the clinical assessment of medicinal products

II. The Biosimilar Fellowship focusing on the assessment of biosimilars.[1]

Aim: The fellowships aim to provide regulatory and scientific expertise in the respective areas. They are based on the 'Train the Trainer' principle, meaning that participants (fellows) undergo specialised seminars on didactics and teaching methods, along with regular subject-specific training sessions to become trainers themselves. Throughout the fellowships, fellows share their acquired knowledge with colleagues both within and outside their agencies, supported by the PharmTrain team. When the fellowship programmes end, the dissemination of knowledge is expected to continue independently, ensuring the sustainability of the fellowships and their contribution to strengthening partner agencies in the future. The involvement of fellows from three different African economic regions fosters networking and standardisation. It is also crucial for continental harmonisation of the evaluation and registration of medicinal products and the establishment of the African Medicines Agency.

Format: The fellowships consist of three components:

Regular online trainings

In online trainings, both BfArM-affiliated and external experts share their knowledge with the fellows. Interactive elements and practical assignments reinforce learning. In the Clinical Fellowship, fundamental knowledge on clinical, pharmacological, and regulatory aspects of various diseases and their treatments is provided, whereas in the Biosimilar Fellowship, the focus is on assessing the pharmaceutical quality, non-clinical, and clinical data of biosimilars.

Annual two to three-week workshops at the BfArM

During the workshop at the BfArM, fellows gain practical experience in the assessment of medicinal products using dossiers and have direct interaction with BfArM experts. Additionally, they gain insights into national and EU medicine regulations.

Development of a training manual

For the manuals, fellows create training units with practical examples. Alongside a slide presentation, written annotations (Facilitator's Notes) assist future trainers in preparation and adhering to standards. Initially, the trainings are piloted with other fellows in online sessions, then conducted by various trainers at agency and regional levels, either online or in-person.

[1] A biosimilar is a biological product that is shown to be highly similar in terms of its quality, safety and efficacy to an already licensed reference product. Source: WHO “Guidelines on evaluation of biosimilars, TRS 1043, Annex 3”, April 2022

I. Clinical Fellowship

Partner agencies: FDA (Ghana), MCAZ (Zimbabwe), SAHPRA (South Africa), TMDA (Tanzania)

Number of participants: 12 fellows

Duration:  

  • January 2019 - December 2022 (RegTrain-PharmTrain project)
  • January 2023 – December 2025 (PharmTrain2 project)

Highlights:

II. Biosimilar Fellowship

Partner agencies: FDA (Ghana), MCAZ (Zimbabwe), SAHPRA (South Africa), TMDA (Tanzania)

Number of participants: 10 fellows

Duration:

  • January 2023 – December 2025 (PharmTrain2 project)

Highlights:

eLearning for the Assessment of Medicinal Products

The PharmTrain2 eLearnings are being developed by the project team in collaboration with partners and offer two specific online training courses on the following topics:

  • Assessment of Product Information
  • Basics of Assessing Biosimilars.

Aim: Tailored for professionals in medicines regulatory authorities, these online courses support expanding knowledge in these areas and strengthening regulatory competencies. The eLearnings allow for a deeper understanding of prerequisite in drug registration and focus on practice. They deliver digital learning content, ensuring flexible and efficient learning opportunities, irrespective of time or place. The courses enable a sustainable transfer of knowledge across regions and continents, while consistently conveying the same standards and requirements. This promotes harmonisation of drug registration processes.

Format: The eLearning courses are provided on a user-friendly platform free of charge after registration.

  • Organised into 10 to a maximum of 45-minute learning units
  • Supplementary links to additional resources or literature
  • Test for each learning unit as a learning achievement
  • Issuance of a certificate of participation for completing the entire course

Period:

  • January 2019 - December 2022 (RegTrain-PharmTrain project)
  • January 2023 – December 2025 (PharmTrain2 project)

Highlights:

  • Completion of the eLearning on “Clinical Assessment of Product Information” (online)
  • eLearning on “Assessment of Biosimilars” (in development)

Interested assessors are invited to register for the eLearning on "Clinical Assessment of Product Information" by contacting ghpp.pharmtrain@bfarm.de .