Each year, the Drug Information Association (DIA) holds a conference in the USA (and another in Europe) on the topic of Document Management and Agency Submissions. These conferences have been held for longer than I can remember, but at least the past 20 years.
A real highlight of these conferences is getting the scoop from the Regulatory Agencies on what’s coming and what’s important to them (since they govern the process and approval of authorization to sell drugs). What’s better than San Diego, sun and some inside scoop?
Unfortunately, some of the best laid plans go awry.
Due to the current government shutdown here in the U.S., the FDA was not allowed to attend and therefore the agenda had to be adjusted. Attendees were not happy about that but there was still plenty to discuss based on existing programs.
We had a sizable team attending as well as booth presence. I have received comments from the DIA Program committee that it is sure good to see us at DIA events this year. The program committee is happy to have us and we’re happy to be here.
There were several important points discussed at the annual meeting that deserves reiteration. In the absence of the FDA, the audience formulated many questions that they would have for the FDA and the promise of the EDM Program committee was that they (with avid note-taking) would present the questions to missing representatives so that they could answer them during a webinar that has been promised. Everything from:
- Possible requirement for Digital Signatures
- An electronic IND
- Site selection data sets
- Datasets for nonclinical studies
- Electronic application forms
- Action to take when a reviewer asks for something not in the specifications
- Timeline for IDMP implementation
- To tracking correspondence (XML, two-way)
Several international regulators did attend and gave some helpful insight from Health Canada and the Danish Health and Medicines Authority.
Key topics that were discussed by industry representatives covered such topics as:
- xEVMPD, IDMP and UDI standards and their impact on RIM (Regulatory Information Management) and SmPC
- Direct access to the eTMF for Health Authority inspections and changes in the way future inspections will be conducted
- The complexity of TMF and the role and future impact of (emerging) standards such as CareLex (OASIS), CDISC, risk-based monitoring on Clinical Trials
- Clouds including definitions, solutions and progress towards industry acceptance
- • Industry implementations of Digital Signatures
The attendance this year was lower than usual. We don’t know if the cause was the missing FDA or that California was too far away for a large bolus of industry attendees to travel.
It was too bad that so many people missed the interesting subjects and the great chances to network with their peers. It was a successful conference in spite of the challenges.