Heba Jalil
Heba Jalil is an associate in the London Life Sciences practice group. She has acted for pharmaceutical companies in relation to a range of litigation and regulatory matters, including public inquiries regarding medicinal products and product liability litigation before the UK courts.
Ms. Jalil assists with commercial transactions involved in the development and commercialisation of medicinal products, with particular experience in drafting and negotiating supply and distribution agreements.
Practice Area
Panel
- Contributing Author
Qualified Year
- 2024
Qualification
- BA, Jurisprudence (2020)
Education
- University of Oxford (2020)
1 Contributions by Heba Jalil
PRACTICE NOTES
Advanced therapy medicinal products: EU and UK regulation, classification, clinical trials, manufacturing and authorisation; pharmacovigilance, traceability, GMOs, hospital exemption, and key reforms including SoHO, HTA and UK point-of-care
Advances in medicine, biomicrobiology and biotechnology have given rise to a state-of-the-art group of medicinal interventions that deploy gene therapy, somatic cell therapy and engineered tissues to prevent, manage or even cure human disease. The newness, intricacy and variety of these products has required fresh regulatory instruments, both legislative measures and guidance, to strike an appropriate balance between risks and patient benefits. In the EU and the UK, lawmakers classify this group as ‘advanced therapy medicinal products (ATMPs)’ to safeguard the highest standards of public health while recognising their unique challenges, particularly around clinical trials, manufacturing and pharmacovigilance. Yet oversight of genetically modified organisms (GMOs) used as starting materials for ATMPs remains a national matter and therefore varies from one Member State to the next. These divergences have produced a complicated regulatory environment for ATMPs. Oversight of tissues and cells is likewise presently handled at national level, although such inconsistencies are expected to continue only until 2027, when a revised EU regulation is anticipated to take effect. This Practice Note examines what constitutes an ATMP and how it is regulated, and considers where exceptions apply across clinical trials, manufacturing obligations, pharmacovigilance requirements, and related EU and UK processes today to...
Life Sciences
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