www.symmetric.events
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Submitted URL: https://cjftk04.na1.hs-sales-engage.com/Ctc/ZQ*23284/cjFTK04/Jll2-6qcW7Y8-PT6lZ3pfV6vJTH73LZMYW2PMfLD4Y-QhlW99VKPf7KGcwtW990XkR6dlm1vW6t...
Effective URL: https://www.symmetric.events/event/cmc-regulatory-affairs-for-nucleic-acids/
Submission: On November 21 via manual from IN — Scanned from US
Effective URL: https://www.symmetric.events/event/cmc-regulatory-affairs-for-nucleic-acids/
Submission: On November 21 via manual from IN — Scanned from US
Form analysis
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The law states that we can store cookies on your device if they are strictly necessary for the operation of this site. For all other types of cookies we need your permission. This site uses different types of cookies. Some cookies are placed by third party services that appear on our pages. You can at any time change or withdraw your consent from the Cookie Declaration on our website. Learn more about who we are, how you can contact us and how we process personal data in our Privacy Policy. Please state your consent ID and date when you contact us regarding your consent. Do not sell or share my personal information Deny Allow selection Customize Allow all EUR USD CMC/Regulatory Affairs for Nucleic Acids Online Training Early Bird Offer: Save €200 on Feb & March 2025 courses with code 200EBOA4. Register by Nov 30, 2024. * Training Courses * In-house Training * Consulting * Clients * Trainers * Blog * About us * Contact * Training Courses * In-house Training * Consulting * Clients * Trainers * Blog * About us * Contact * Training Courses * In-house Training * Consulting * Clients * Trainers * Blog * About us * Contact CMC/REGULATORY AFFAIRS FOR NUCLEIC ACIDS DNA, RNA, and PNA Active Pharmaceutical Ingredients, Drug Substances, and Drug Products 19 – 21 February 2025, live online training Request agenda Request agenda Your name * Your company * Your email * Your contact number * Register SUMMARY This intensive 3-day course provides a deep dive into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) and Regulatory Affairs in the development of nucleic acid therapeutics. Participants will gain a thorough understanding of the quality requirements, regulatory expectations, and best practices necessary to navigate the complex landscape of nucleic acid drug development. LEARNING OBJECTIVES * Understand the regulatory frameworks governing nucleic acid therapeutics * Develop effective CMC strategies to ensure product quality and compliance * Implement robust quality control and assurance measures throughout the development lifecycle * Gain insights into manufacturing processes and facilities specific to nucleic acid drugs * Master analytical methods for characterization and stability assessment * Navigate post-approval changes and lifecycle management effectively * Mitigate risks and maintain compliance with regulatory requirements KEY TOPICS * Regulatory Frameworks and Guidelines * CMC Strategies for Nucleic Acid Therapeutics * Quality Control and Assurance * Manufacturing Processes and Facilities * Analytical Methods and Characterization * Stability Studies and Comparability Assessments * Post-Approval Changes and Lifecycle Management * Risk Management and Compliance WHO SHOULD ATTEND? * Regulatory Affairs Specialists * CMC Professionals * Quality Control/Assurance Personnel * Manufacturing Engineers and Managers * Research and Development Scientists * Project Managers and Executives OUR ONLINE TRAINING EXPERIENCE INCLUDES * Our client zone – a single source for all training materials as well as pre and post training communication * Live interactive format via the Zoom platform * Direct interaction with the trainer * Q&As, case studies, polls * Revisit recorded sessions for 7 days * Digital and LinkedIn certificates TRAINERS Dr. Len Pattenden Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA. CMC/REGULATORY AFFAIRS FOR NUCLEIC ACIDS Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio. See the full training agenda See the full training agenda Your name * Your company * Your email * Your contact number * Share This Training * Facebook * Twitter * LinkedIn * WhatsApp * Email * Registration * FAQ * Contact us Online Participation 1 850 € Price incl. VAT: 1 850 € Price per delegate including: Online participation Online workbook & materials Recorded sessions for 7 days Certificate No. of Delegates12345678910 No. of Delegates Buy Now What are the technical requirements to attend the online training? PC, microphone, camera, stable internet connection and the Zoom application. Will the Online Training allow for live interaction? Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform. Can I transfer my registration to a colleague? Yes, you can transfer the registration to a colleague at any time. Can I transfer my registration to a different Symmetric event? Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full. LYDIA MAKORI l.makori@symmetric.events +421 222 200 543 * Register Training Details * Start Date 19. February 2025 01:00 PM Vienna time 12:00 PM London time 07:00 AM New York time 04:00 AM Los Angeles time * End Date 21. February 2025 * Email l.makori@symmetric.events Request in-house What participants said about Symmetric courses "I was happily pleased with the enormous experience of the trainer, i enjoyed it a lot and learned a lot." Senior Development Pharmacist, Orion Corporation "Keep up the excellent standard of training courses!" FDF Industrialisation Manager, Medichem Manufacturing "I have received a lot of knowledge that will be of big use for my profession." Quality manager, Vironova AB "Thank you for a very informative training course. The timing of start/break/finish was perfect." Clinical Project Manager, Regen Lab "Would highly recommend this course, great practical insights throughout helped to make it all very real, many thanks." Head of API and Contract Manufacturing, Zentiva Group "Very informative and memorable training course for me." Quality Vice President, Darou Pakhsh "The trainer was very knowledgeable about the topics and was able to answer all questions." Drug Product Subject Matter Expert, Pfizer Related Training Courses You might also like these training courses. CMC Statistics * CMC * Pharma & Biotech * Public & Online Training 24. March 2025 13:30 Upcoming CMC Regulatory Compliance for ATMPs * CMC * Pharma & Biotech * Public & Online Training 24. March 2025 12:00 Upcoming Manufacturing of Antibody Drug Conjugates * CMC * Pharma & Biotech * Public & Online Training 2. April 2025 14:00 Upcoming JOIN SYMMETRIC NEWSLETTER Sign up today so you don’t miss any special offers, new events and pharma breaking news. 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