- The current focus on EMA’s PLM portal is crucial for regulatory professionals as it directly impacts how regulatory procedures will be managed in the near future
- This webinar is directly related to the currently ongoing activities of EMA’s PLM implementation in preparation of IDMP
- The current PLM implementation activities as part of the long-term roadmap for IDMP implementation, which will have a large impact on how the medicinal product life cycle will be managed in the coming years
- The webinar will focus on practical aspects related to the topic, specifically from a data management point of view to address Industry challenges
This webinar will include a 45-minute presentation and 10 to 15 minutes of Q&A.
Sowmya Raju, Senior SME – Regulatory Services
Sowmya Raju is our Senior Regulatory SME with strong experience in xEVMPD, IDMP, RIMS, Regulatory Affairs. She is a RISS TG member for IDMP, CSV, Validation and implementation support.
Michiel Stam, Director of Regulatory Information Management
Michiel started his career 15 years ago in eCTD publishing and submissions, before shifting focus to Regulatory Information Management (RIM). He is also the former product owner of Dossplorer™. Currently Michiel holds the position of Director Regulatory Information Management and provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. Michiel has worked on various eSubmission projects including the preparation and submission of initial MAA’s and post-authorization maintenance applications for agencies in the EU (CP/MRP/DCP and Nationals), US (NDA/BLA/IND) and other regions such as GCC and Switzerland.
Professionals involved in Regulatory Affairs, Pharmacovigilance, CMC, Quality Assurance, and information technology within the pharmaceutical and regulatory domain.
This event is tailored for individuals seeking to enhance their understanding of EMA PMS activities and contribute to global collaboration in medicinal product lifecycle management.
Advertising, Promotion and Labeling, Chemistry, Manufacturing and Controls (CMC), Compliance, Product Lifecycle, Professional Development/Training, Quality Assurance and Control, Regulatory Intelligence/Policy, Supply Chain Management
Celegence provides regulatory outsourcing services and can take either full responsibility for regulatory deliverables or engage remotely and/or on-site in operational activities within your company. Our team has vast experience with the compilation, submission, and maintenance of regulatory dossiers, registration tracking, IDMP, xEVMPD, document, and data migration. The innovative technologies at Celegence help Life Science organizations reduce their costs and time to market to support product development and submission strategies. Our solutions enable optimal reusability and consistency by transparent management of recordings and documentation of regulated information, across data, documents and dossiers.
We are happy to share our insights with you during this webinar and hope that you can join us then.