Date: June 15-17, 2021
- The conference aims to ensure compliant pre-market and post-market operations
- The event will feature case studies, panel discussions, and presentations by 15+ industry professionals holding senior positions at various pharmaceutical and biotechnology companies
- Attendees should expect to get their unique needs addressed as the program includes Q&A sessions after every discussion
- There will be 30-minute virtual networking sessions daily
As an organizer whose mission is to propel highly regulated industries forward through platforms of curated executive learning with a focus on quality, Q1 Productions invites you to one such platform: the 7th Annual Global Regulatory Affairs CMC: Chemistry, Manufacturing, and Controls Conference, a virtual event to be held on June 15-17, 2021.
The conference aims to ensure compliant pre-market and post-market operations using comprehensive product lifecycle management strategies and strict supply chain change-control processes. In this regard, it will explore the evolution of products throughout their lifecycle and discuss guideline changes, as well as the challenges emanating from global regulatory harmonization.
Designed to better equip CMC teams with knowledge on how to deliver uninterrupted product supply chains, streamline approval processes, and showcase products’ efficacy, quality, and chemical makeup in an evidence-based manner, the virtual conference will feature case studies, panel discussions, and presentations, all facilitated by industry professionals.
To maximize knowledge acquisition and engagement, the learning will be delivered in three half-day modules scheduled from 9:30 am to 1:15 pm CST. Module 1 will have nine facilitators holding executive positions at various pharmaceutical and biotechnology companies wherein they oversee regulatory affairs or CMC operations. The conference, to be held on the Q1 Productions virtual event app, will kick off with a keynote panel in which five panelists will examine the topic Navigating the Continually Dynamic CMC Landscape. Day 1 will include three additional presentations and a 30-minute virtual networking session and coffee break.
Module 2 will pick up where the facilitators will left on day one by exploring the regulatory approvals in Brazil and China. Like the first day, the second day will also feature a virtual networking session and coffee break, followed by a presentation by the Head, Global Chemistry, Manufacturing & Controls at Merck (NYSE: MRK), Ganapathy Mohan, who will decode the standards related to nitrosamine data requirements. Later, Christina Markus, Deputy Chair, FDA & Life Sciences Practice at King and Spalding, will discuss the CMC development and regulatory considerations for cell and gene therapies, the last presentation of the day.
Module 3 will feature two presentations and a session series titled Quality and regulatory requirements for a product’s starting materials, in which presenters Arul Joseph, the Senior Director, Pharmaceutical Development & Clinical Supply Chain at Avanir Pharmaceuticals and Ambarish Singh, the Head of Regulatory CMC at Constellation Pharmaceuticals (NASDAQ: CNST), will each present case studies.
Attendees should expect to gain insights and a comprehensive understanding of regulatory affairs in CMC and learn from industry experts with many years’ experience currently holding senior positions in their respective companies.
What’s more, attendees will get to customize their experiences and seek answers to their unique concerns and questions during live Q&A sessions after each discussion. They should also anticipate interactive and fun sessions owing to Q1 Productions’ emphasis on using different types of session formats, as well as scheduling virtual networking sessions.
With all these characteristics, the event indeed espouses Q1 production’s mantra – Dedicated to Quality First.
For more information regarding the event, please visit https://ibn.fm/vpOjH