Constructing compliant and comprehensive regulatory submission dossiers for us and global health authorities with a thorough understanding of document content authoring requirements, submission standards through to outsourcing considerations.
Pharmaceutical industry medical writers and submission specialist have been tasked with the growing challenge of interpreting and explaining exceedingly large amounts of clinical trial data along with supportable results into readable and easily comprehensible documents for health authority review. The generation and completion of quality and compliant product submissions is seemingly complicated by the varying content and formatting needs required by individual countries.
As major international regulatory bodies continue to evolve and make great strides to standardize the format and content necessary for all approval dossiers, pharmaceutical organizations continue to eye the possibility of large simultaneous multi-market product launches. Simultaneous global roll-outs however are a long way off as the regulatory environment is still seemingly complex and inconsistent. Therefore, pharmaceutical medical writers and regulatory operations executives must possess a comprehensive knowledge and understanding of key submissions dossier guidelines and regulations to ensure the approval for all new therapeutic drugs.
Building on the knowledge share of the 2nd annual program, the 2014 program will showcase industry experts in regulatory writing and submissions formatting, who as presenters will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will cover a plethora of areas from content authoring strategies, global submissions standards, submission rapid response management through to authorship granularity and cohesiveness. Designed for writers and submissions specialists this two-day executive level meeting will provide participants with extensive, in-depth learning and knowledge share. Through case study driven presentations, as well as round table panel discussions complemented by multiple networking opportunities, the program will foster a sense of collaboration and promises to be a valuable program to those who are looking to streamline and enhance regulatory submission operations.
Who Should Attend This Program:
Executives that will find this program of greatest relevance are those currently working to enhance the regulatory writing and submission operations within pharmaceutical and biotechnology corporations. Job titles of those executives that will find this program to be most applicable to their job functions include:
- Medical Writers
- Regulatory Writers
- Regulatory Affairs
- Regulatory Operations
- Submissions Specialists
At this time, there are a variety of sponsorship and exhibition opportunities available for companies wishing to increase their visibility and participation in the program, ranging from keynote speaking opportunities through to exhibitor and documentation sponsors. Organizations most suitable for this type of exposure provide services and solutions including:
- Regulatory consulting services
- Submission development specialists
- eSubmission software solutions
- EDMS-electronic data management systems
- Clinical data management software
- Medical writing/technical writing contractors
For further information, please see our website.