Signal Detection
The online event was part of the 3rd edition of the international conference Biotech Atelier 2020
PharmaLex Bulgaria has organized another great webinar during Biotech Atelier 2020. The company presented an online event dedicated to the topic “Hospital Exemption (HE) for ATMPs” gathering leading experts from different countries to share their knowledge and experience in the field.
The webinar aimed to provide a comprehensive overview of the requirements for adopting Hospital Exemption procedure for ATMPs, emphasizing key opportunities and challenges.
During the webinar, the EU ATMPs Hospital Exemption landscape was discussed by Arūnas Žebrauskas, Head of Project Management department from State Research Institute Centre for Innovative Medicine in Vilnius, who presented the criteria set in the regulations for granting HE as well as the specific interpretations and additional clarifications needed from the regulatory side.
Furthermore, Dr. Tatjana Ivaskiene, Director of State Research Institute Centre for Innovative Medicine in Lithuania provided a very useful example of the situation in Lithuania as a reference country where the HE pathway is already in place.
Dr. Liliya Evtimova- Tichev, Quality Assurance Validation Specialist in Cell and Gene Therapy in CMO plant in Lonza Netherlands, provided a thorough analysis of the manufacturing challenges associated with the development of ATMPs under the Hospital Exemption pathway from the public and private facilities perspective.
The final presentation of the event was held by Dr. Prof Bams Abila, visiting Professor of Biologics & ATMPs at King’s College London, UK, and Chief Medical Officer for CMED, shared his experience with ATMPs. He provided examples of products used as starting materials for the manufacturing of ATMPs. Hematopoietic Stem Cells (HSC) derived from human umbilical cord blood used in hospitals in the UK for individual patient needs under the HE pathway.
“Hospital exemption procedure allowed the use of unauthorized ATMPs in individual EU member states to patients with high unmet medical needs. This procedure is a unique and specific opportunity to bypass the mandatory centralized marketing authorization that is time-consuming, requires significant budget costs and long regulatory approval process”, said the moderator of the event Panko Stanchev, Pharmacovigilance specialist from PharmaLex Bulgaria.
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