Closing Remarks Sharing the Key takeaways for the Regulatory Informatics Track by Michiel Stam Celegence/Qdossier participated as exhibitors and speakers during this year’s Regulatory Submissions, Information, and Document Management Forum (RSIDMF) from February 13-15, 2023, in Bethesda, Maryland. Celegence Presentations, Short Courses & Other Contributions throughout the forum included the following: Short Course: On
IDMP Process Optimization - Webinar Transcript with Wim Cypers Wim Cypers has a long-standing experience in converting business requirements into application functionality and consistently showing industry thought leadership through speaking engagements at several industry events. He has applied his pharmacist training into a keen understanding of how to solve complex business issues. For
Overview of eCTD Submission Modules and Format It would be a vast understatement to say that new drug and biologics applications are “complicated.” New submissions can include hundreds or thousands of documents. So, it’s not hard to figure out why regulatory reviewers wanted to standardize the submission format, cross link documents within submissions and
IDMP Data Management - Webinar Transcript with Wim Cypers Wim Cypers has a long-standing experience in converting business requirements into application functionality and consistently showing industry thought leadership through speaking engagements at several industry events. He has applied his pharmacist training into a keen understanding of how to solve complex business issues. For
Navigating eCTD Submissions in China - Webinar Q&A with James Ma Celegence, a Global Regulatory Affairs Services & Technology company for the Life Sciences Industry, partnered with dMed Biopharmaceutical in September, 2021, to offer a webcast titled “Navigating eCTD Submissions in China”. If you were not able to attend this webinar, check the online
Navigating eCTD Submissions in China - Webinar with James Ma James Ma is responsible for the development and implementation of information technology strategies to enhance the company’s competitive edge. He leads technology platform design, cross-functional business solution building e.g., regulatory and eCTD submissions, infrastructure set up, as well as information security enhancement. James
What Is Medical Writing? Medical writing is a vital component of gaining and maintaining a drug’s market access. There are a variety of components necessary, but a Company Core Data Sheet (CCDS) requires a particularly demanding amount of effort from internal regulatory affairs teams. There are many moving parts to creating and/or updating CCDS
What are Ad/Promo Submissions? The promotional labeling and advertising materials, together known as promotional materials for human prescription drug products, are to be submitted to the FDA (Food and Drug Administration) once the drug product has been approved by the FDA. These submissions are processed on a 2253 form, which is the Transmittal of
How to Optimize the ROI on Your RIMS Solution Webinar Jonathan Sanford has worked in the field of Regulatory Operations for the past 18 years and has over 30 years of pharmaceutical experience. He has managed a team of Regulatory Operation professionals responsible for publishing regulatory dossiers across Europe, Asia, and Latin America. He
China eCTD Requirements – Center for Drug Evaluation (CDE) Info Draft information on the future of electronic common technical document (eCTD) submissions in China has been published by the China Center for Drug Evaluation (CDE) in recent months. Although things may change between this draft information and the final specification, expected sometime in
