Mantej (Nimi) Chhina
Company: BioMarin Pharmaceutical
Job title: Executive Director
Seminars:
MANAGING COMPLEX MULTINATIONAL SUBMISSIONS 1:00 pm
Differentiating key strategic approaches between collaborating with the FDA, EMA and other health authorities Assessing how expedited program criteria and benefits differ between the two bodies Addressing key regulatory CMC differences Utilizing these differences to help inform clinical and manufacturing strategies Top tips for drug sponsors working across these different regionsRead more
day: Workshop Day - track c PM
Panel Discussion: A 101 in Expedited Programs for Gene Therapy 2:00 pm
Outlining the practicalities of gaining FDA expedited designations Criteria for designation and best practices with regulatory touchpoints Considerations for successful interactions with CBER reviewers Common reasons for denial of RMAT applicationsRead more
day: Regulatory - PM
Exploring an Intricate Global Regulatory Landscape 10:55 am
day: Regulatory - AM