In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming supporter of new and innovative healthcare technologies and products. Since its launch, the Innovative Licensing and Access Pathway (ILAP) scheme has attracted continual attention of the industry. It has been one of the great successes, but it has also raised numerous queries.
In this session, we aim to guide your way through the application process and key noticing points of ILAP toward your marketing application and beyond, by answering questions such as:
- Can US person be an Applicant?
- Do Applicants get priority for other procedures/ Expedited development?
- Do Applicants need to show clinical data?
- At which stage do we recommend ILAP for Applicants?
- Is ILAP useful for EMA application?
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Featured Speakers
Zoran Simic
Medical Director, Regulatory Science
Zoran is a Medical Director at VCLS. He has significant expertise in the assessment of Orphan Drug Designation, EMA Scientific Advice, early access pathways and Marketing Authorisation Applications (including ORBIS and ILAP projects) from medical aspects at UK MHRA and EMA. Zoran spent over 10 years at the MHRA working as a Senior Medical Assessor and as the Biologicals and Biotechnology Unit Manager. His experience also covers the oversight of scientific guidelines and procedures (such as for Advanced Therapies, Biosimilars, Post-Brexit regulatory pathways and Expedited rolling review of emergency medicinal products) and authoring papers for expert advisory groups.
Lavaniya Thanabalasundaram
Regulatory Scientist
Lavi has over 8 years of experience in academia, pharmaceutical industry and consulting. Her expertise is in research and development of tissue engineered products, cell engineering and exosomes. She also has in-depth experience in the design and implementation of global regulatory strategies for the UK including preparation of UK Regulatory Roadmaps, Scientific Advice and Paediatric Investigation Plans, etc.
