11 November - 15.00-16.00 GMT

Come on an exciting journey with us as we navigate the ever changing landscape of Regulatory Affairs.  At Roche we are pushing the boundaries of drug development and driving towards bringing better medicines for patients around the world. Topics covered at this webinar will include:

• Applying Project Orbis
• Electronic Product Labelling
• The new Clinical Trial Regulation
• How Medical Writing is evolving

Why should you join us...
• We will highlight ways in which the regulatory environment is evolving
• Hear personal perspectives from experienced team members
• Learn more about the diverse career paths at Roche and potential opportunities for your career

Audience

Anyone interested in learning more about regulatory affairs...

Speakers

Narissa Mulchan (Regulatory Associate Program Director)

Narissa Mulchan joined Roche in January 2019, is the Associate Program Director, where she develops global regulatory strategies for early stage, late stage and marketed oncology products. Narissa received her Diploma (Hons) in Pharmaceutical Regulatory Affairs and Quality Operation from Seneca College and her BSc (Hons) in Neuroscience and Psychology from the University of Toronto. Prior to joining Roche, she was a Regulatory Affairs Manager at Mapi Life Sciences Canada Inc, an ICON PLC Company where she focused on shaping EU and International Regulatory Strategies. 

Nisha Modha (Regulatory Labelling Team Leader)

Nisha Modha joined Roche in 2010, she is a Regulatory Labeling Team Leader, and has previously held the role of Global Process Owner of End to End Labelling, overseeing compliance in this area. During the 11 years at Roche she has mainly worked in the area of Oncology and has a keen interest in the advances in digitalisation. She  is a member of the Inter-Association Task Force (IATF) for electronic product information, which is part of EFPIA. 
Nisha has a BSc (Hons) in Physiology & Pharmacology from The Nottingham Trent University and went on to study for an MSc in Molecular Pharmacology at the University of Manchester. Prior to Roche, Nisha worked at GlaxoSmithKline as a research scientist working within the area of neuroscience, in 2005 she moved into their Regulatory Affairs Labelling department.

Lizzie Thomas (Regulatory Documentation Scientist)

Lizzie Thomas joined Roche in 2019 in Regulatory Documentation, and is currently a Regulatory Documentation Scientist (also known as a ‘Medical Writer’ in industry). Lizzie has a BSc (Hons) in Pharmacology from the University of Bath, and completed a year in industry at pharmaceutical manufacturing company, Bath ASU, as part of her degree. Following graduation, Lizzie joined Roche as part of the Regulatory Graduate Scheme within the Documentation group, and gained a permanent position at the company in 2021. 

Jo Molloy (Regulatory Operations, Global Head of Clinical Trial Management)

Jo joined Roche in 2012 as a manager in International Regulatory and later became a team lead in the group.  In 2020, Jo moved to Regulatory Operations as the Global Head of Clinical Trial Regulatory Management (CTRM).  In this job, Jo provides coaching and guidance to the team and is inspired by seeing individuals thrive in a supportive and empowering environment. In addition, Jo is the Roche EFPIA representative to the CREG CTR Pillar and the global process owner for clinical trials. Prior to Roche, Jo worked at Abbvie and Pfizer in Regulatory Affairs and holds a BSc (Hons) in Physiology and Pharmacology from the University of Nottingham Trent.  

This webinar is sponsored by Roche.

Disclaimer: Whilst TOPRA is running this webinar for Roche, this is not an endorsement of Roche, Roche's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

• Members: free
• Non-members: free

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