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REC Webcast: Nitrosamines

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Monday, 28 February 2022 (4:00 - 5:15 PM) Central European Time

Following the EMA review around nitrosamine risk potential in medicinal products, under Article 5(3) of Regulation (EC) No 726/2004, in 2020 the CHMP asked European marketing authorisation holders to review all chemical and biological human medicines for the possible presence of nitrosamines and to test products at risk. The presence of N-nitrosamines in human medicinal products is required to be mitigated by appropriate control strategies and by the design or adaptation of the manufacturing processes aiming to prevent formation of and contamination with nitrosamines whenever possible.

A Q&A session will be provided at the end of the sessions, where questions in the chat will be discussed.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speakers will follow the presentation. 

Learning Objectives

This webcast will share experiences in evaluation of nitrosamine presence in OTC medicines from an industry perspective, highlighting some of the obstacles that have been overcome and the ongoing challenges.

Learning Level: Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

This event is brought to you by the RAPS European Council (REC) to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.

Explore our up-coming European workshops produced in collaboration with the RAPS European Council (REC). Learn more and register

 

This webcast is available to global regulatory professionals.

Registration Fees & Deadlines

24 January 2022 - 28 February 2022: Member € 0 | Nonmember € 25

Agenda

  • Welcome attendees
  • Housekeeping notes
  • Introduction of the topic and speakers
  • Experiences from an OTC Industry Perspective
  • Tetrazole sartan - Journey so far>
  • Q&A & closing remarks

Speakers


Pallavi Trivedi, MPH, RAC, Trident Pharmaceuticals Limited and Spinos Clinical Research Ltd, UK

Pallavi Trivedi, MPH, RAC is Head Of Global Regulatory Affairs and Compliance, Trident Pharmaceuticals Limited and Spinos Clinical Research Ltd, UK and has more than 10 years of industry experience with international pharmaceutical companies, including Novartis, Mylan, Glenmark and Dr. Reddy's Laboratories. She specializes in regulatory strategy and intelligence, CMC and regulatory submissions for EU, US and Canada. She is an active volunteer for RAPS and serves as a member of the Regulatory Focus Board of Editors, member of RAPS European Council and a Europage correspondent. She is also a chapter contributor to the book, Fundamentals of EU Regulatory Affairs and Fundamentals of International Regulatory Affairs.

 

Sharon Porter, CMC Regulatory Affairs Director - Pain Relief, GSK

Sharon is a CMC Regulatory Affairs Director with responsibility for pain relief products within GSK Consumer Healthcare, based in Weybridge, Surrey UK. Prior to joining GSK as part of the Joint Venture, Sharon was a Senior Manager working in the Global Regulatory Chemistry, Manufacturing, and Controls (CMC) Team within Pfizer Consumer Healthcare, supporting new product introductions and lifecycle maintenance across the diverse range of Pfizer Consumer Healthcare products.

Prior to this, Sharon worked for a number of years within the Product Design/Global Research and Development groups, with responsibilities for searching for externally-led innovation, management of third party development projects and internal development programmes covering a wide range of technologies and consumer products. Sharon joined the Whitehall/Wyeth GR&D Labs as an Analytical chemist.

Before joining Wyeth, Sharon worked at the Veterinary Laboratories Agency, where she led a team specialising in the development of analytical techniques and their application to the monitoring of trace levels of veterinary drug residues in meat taken from animal at slaughter and investigating poisoning incidents in farm animals.

Whilst working at the vet labs, Sharon passed the Graduateship of the Royal Society of Chemistry (Part II) examinations and gained a MSc in Analytical Chemistry with Distinction from Birkbeck College, University of London. She contributed a book chapter on HPLC to a textbook on residues analysis and has numerous publications. Sharon is a Chartered Chemist/Chartered Scientist and is a Fellow of the Royal Society of Chemistry.

Event Policies

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

 To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

 

Contact Us

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.