ABOUT THE CONFERENCE

With the goal to swiftly release new products to the market, pharmaceutical and biotechnology regulatory publishing and submissions executives are challenged to present comprehensive and technically flawless product dossiers to regulatory authorities globally. The continued push for harmonized global regulations and impact of new technological capabilities has confronted regulatory operations executives with a multitude of hurdles to overcome while ensuring timely and compliant dossier submissions. Building on knowledge share and successes of past years, the 2018 program will showcase industry experts in regulatory operations and publishing, who will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will address a multitude of topics ranging from Module 1 guideline updates and implementation strategies, expanding on differing global dossier and data requirements, and exploration of artificial intelligence’s potential to impact submission development processes.

CORE TOPICS TO BE ADDRESSED:

• Guidance and compliance considerations for Module 1 specifications
• Successful marketing submission in accordance with new Module 1 guidelines
• Current guidelines for identification of medicinal products (IDMP)
• Impact of AI and digital innovations on regulatory publishing processes
• Regional Case Studies: Global compliance and dossier requirements
• Integrating publishing systems and legacy product submissions post M&A
• Workshop: reducing the risk of regulatory rejections due to technical deficiencies
• Creation of documents for re-use in multiple global dossiers
• cDISC data standards and impact on product dossier development
• Importance of comprehensive RIM systems to support dossier compilation
• Impact of EDMS on company agility and change management capabilities
• Real world evidence influence on submission data requirements
• Streamlining timeline and project management strategies
• Integrating project management into registration strategies and operations
• Collaboration and relationship management best practices with external partners
• Small Groups: Publishing and management systems best practices

ABOUT THE CONFERENCE

With the goal to swiftly release new products to the market, pharmaceutical and biotechnology regulatory publishing and submissions executives are challenged to present comprehensive and technically flawless product dossiers to regulatory authorities globally. The continued push for harmonized global regulations and impact of new technological capabilities has confronted regulatory operations executives with a multitude of hurdles to overcome while ensuring timely and compliant dossier submissions. Building on knowledge share and successes of past years, the 2018 program will showcase industry experts in regulatory operations and publishing, who will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will address a multitude of topics ranging from Module 1 guideline updates and implementation strategies, expanding on differing global dossier and data requirements, and exploration of artificial intelligence’s potential to impact submission development processes.