Harpreet Panesar Email & Phone Number

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

• Lead for updating local Materials Review Grid, Promotional and Non-promotional SOPs.• PSP Committee Chair, bringing together various stakeholders within the affiliate and EU to problem solve and action issues relating to local PSPs. • Working with labelling and manufacturing to agree on implementation of new packaging after the end of the BREXIT transition period.• Collaborating with the multi-channel team to provide guidance to the field force on new ways of working during the pandemic, ensuring business continuity and continued interaction with HCPs. • Prepare, review, and submit documents to accompany Clinical Trial Applications (CTAs) and amendments to the MHRA and HPRA, including first in man studies with novel compounds.• Provide local Regulatory expertise to ensure that submissions meet local requirements.• Interact with MHRA and HPRA as required. • Review and approve Site Initiation Packages to allow Clinical sites to be activated.• Upload amended/new SPCs and PILs for Amgen products onto the electronic Medicines Compendium and medicines.ie websites in a timely manner. • Communicate to Product Brand Teams recall timelines for materials after Product Information updates. • Prepare or update abbreviated Prescribing Information to accompany promotional material in the UK and Ireland.

Thousand Oaks, Ca, Us

• Prepare, review, and submit documents to accompany Clinical Trial Applications (CTAs) and amendments to the MHRA and HPRA, including first in man studies with novel compounds.• Provide local Regulatory expertise to ensure that submissions meet local requirements.• Interact with MHRA and HPRA as required. • Review and approve Site Initiation Packages to allow Clinical sites to be activated.• Upload amended/new SPCs and PILs for Amgen products onto the electronic Medicines Compendium and medicines.ie websites in a timely manner. • Communicate to Product Brand Teams recall timelines for materials after Product Information updates. • Prepare or update abbreviated Prescribing Information to accompany promotional material in the UK and Ireland.

Raleigh, Nc, Us

• Acted as Global Regulatory Lead on Clinical Trials which involved project managing submissions of Clinical Trial Applications to Regulatory Agencies and Ethics Committees, preparing essential document checklists, and ensuring key documents like contracts are in place to allow study start up. • Prepared and reviewed responses to questions from Regulatory Agencies and Ethics Committees.• Undertook User Leaflet testing and prepared the user leaflet testing reports.

• Compiled, reviewed documents, and submitted CTAs and amendments to various Regulatory Agencies worldwide.• Prepared and reviewed responses to questions from Regulatory Agencies.• A key team member of the Chiltern Trial Master File (TMF) committee, this included creating the template regulatory section of the TMF.• Reviewed the Chiltern TMF SOP and Working Instructions.

St-Prex, Ch

• Assisted in the preparation of documents to accompany Marketing Authorisation renewal and variation applications.• Prepared and reviewed documents to accompany CTAs and amendments to the MHRA. • Managed the process for the preparation of new packaging components. This included drafting the initial text, managing the preparation of the electronic files by working daily with an external graphics bureau, and liaising with Ferring manufacturing sites to ensuring timely introduction of the new/revised packaging materials.• Authored the SOPs for Clinical Trial Applications and maintenance work and Marketing Authorisation variations. • Sourcing of a suitable agency for user testing of leaflets and working with them to get the leaflets tested.