Hey Everyone. It has been a few months since my last entry. I trust your holidays were enjoyable. Hopefully you didn’t think about work too much. That’s what this final chapter is going to focus on, actually – not thinking about work. In the previous installments, I talked to you about the tools and teams to help you make regulatory submissions easy. But since I’m going to assume that since I left you alone there for a few...
Executive management may consider creating a strategic plan for in/out-licensing and mergers and acquisitions. This strategic plan should include the technical aspects of such an undertaking. Such topics as systems to be used, network and security, and staff involvement (including when to involve staff) are important strategies to ensure success.
During the out-licensing process it is necessary for the RegOps group to organize and transfer the information and documentation to the new company. This may include the submissions, labeling, correspondence, and other documentation for the product. Additionally a chronology of the product documents, whether that be hard copy, electronic, or both should be included as an “inventory” check.
The draft guidance will be open to comment for a period of 6 months followed by the release of the final version. It will then be implemented 2 years after the final version, bringing us to mandated electronic submissions in Q2 2015.
Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.