• Hello, I am Parminder Kaur

    Expert in: Health

    Personal Info

  • About Me

    REGULATORY AFFAIRS EXPERT KEY AREAS OF EXPERTISE: ? Regulatory intelligence & expert knowledge of global regulatory requirements ? Preparation/ Lead preparation of: ? European and Non-European scientific advice and pre-submission meetings incl. pre-IND, pre-BLA, EOP2/3, Oral explanation meetings and PIP procedures ? Clinical Development Plans, Labelling incl. CCDS, Target Product Profile and IMPD/Regional CMC Documents ? Various modules for MAA & Licence Maintenance incl. variations ? CTA applications ? Orphan Drug Designation- Fabry’s Disease, Scarring post Glaucoma Filteration Surgery, Acute Myeloid Leukemia, Factor VIII, Huntington’s Disease, Sanfilippo B syndrome and Fredrich's Atexia ? Pharmacovigilance ? EU QPPV/Deputy QPPV ? Establishment of risk minimisation plans, pharmacovigilance planning and assessment of benefit vs. risk.; EVPRM & ICSR report exchange with Eudravigilance ? Alignment of PIL & SmPC with RMP updates ? Assistance with pharmacovigilance Inspections ? Product Promotion & Labelling ? Development and maintenance of Company Core Data Sheets incl. global prescribing information (PIL) ? Review and approval of safety variations impacting label/prescribing information ? Oversees local affiliate (LOC) labelling function for review of new labels and changes in existing product labels. ? QC check for compliance with appropriate QRD template ? Compliance with advertisement and promotion in EU & Non-EU countries ? QA & Inspections ? Ensuring effective and robust compliance to quality in all aspects of the site operations and releases ? Formulating change control procedures, review batch records, gap analysis and formulate corrective actions ? GLP and GMP audits/Inspections ? Due Diligence ? Conduct of regulatory due diligence on new product opportunities ? Pricing and Reimbursement ? Developing and executing pricing and reimbursement strategies for new products as well as refining strategies for in-line products TYPE OF PRODUCTS DEALT WITH: Biologicals incl. Biosimilars and Vaccines, small molecules, generics, cosmeceuticals, nutraceuticals/herbals and medical devices THERAPEUTIC AREA EXPERTISE: Oncology, Autoimmune Diseases, CNS, Respiratory, Opthalmology, Dermatology and Infectious Diseases