Life Sciences blog: News, Views, and Guidance
Since November 2011, CSC has been keeping the industry informed about developments around the EVMPD and their implications with a weekly blog. Written by experts both within and outside of CSC, the purpose of the blog has been to stimulate conversation, encourage readers to explore their own issues and challenges, and drive greater understanding around the issues.
We felt it was timely to update and expand the blog to broader industry issues. To start with, the focus of the blog will likely be the myriad issues that surround Regulatory Information Management, given its importance for longer-term management of the EVMPD and other regulatory requirements.
But this is your space – this is where we want you to share and discover issues of importance. So again we encourage your input, whether in the form of a guest blog or simply suggestions of topics that matter to you. We look forward to uncovering the latest trends, attitudes, hopes and even fears of the industry in the revamped Life Sciences Blog in the months ahead.
- 3 January 2013: November 29th and 30th were the DIA 13th European Electronic Document Management Conference (EU EDM for short). I was privileged to be invited to speak there, and hear the latest information from regulators, sponsors and vendors (and sample Munich’s great sausages, pork shanks and schnitzels – sorry Vienna, Munich’s got you on schnitzel). I’ve got several items I’d like to report, but a couple of them are waiting for some of the presentations to be posted to the DIA website (eCTD 4 update, electronic submissions in China). So I’ll start with an update on the latest information on XEVMPD and IDMP, mainly from the presentation by Andrew Marr at the conference.
- 26 December 2012: Regulatory agencies have been more focused on the patient in the past few years, including with regard to patient friendly language on material such as leaflets, cartons, or indeed any promotional material patients come into contact with. The regulations about patient information are already strict in some countries, such as the UK, and now the EMA is putting policies in place to require all countries in Europe to follow suit. The goal is harmonisation across the EU.
- 18 December 2012: The months since the EudraVigilance Medicinal Product Dictionary (EVMPD) became mandatory – 2nd July, 2012 – have seen companies and the EMA begin to settle into what is required of them.
- 12 December 2012: The challenge of managing, updating, verifying, and reporting vast amounts of data is well understood in the pharmaceutical industry. One area where this challenge truly manifests itself is with the CCDS, or company core data sheet.
- 5 December 2012: If you take a look at the design for eCTD 3.x and the Module 1 DTDs used by various countries, they’re loaded down with a huge number of elements containing the element. The 2006 version of FDA’s Module 1 specification has over ninety elements containing the element (which means they can specify documents), six of those just for forms. If another form comes along, that would require another element, meaning either new versions of software, or at least some engineering to deliver a new configuration to output to the new DTD.
- 21 November 2012: The one constant in life is change, and in today’s world change is rapid. That’s been made abundantly clear in the workplace as we see a significant trend towards the adoption of mobile devices for business use. This was one of the topics of conversation during CSC’s September CAB meeting in Nashville, Tennessee.
- 15 November 2012: There’s no doubt that we, as an industry, all face similar challenges around regulatory submissions and getting a handle on our regulatory information. But the scale, emphasis, and needs differ quite significantly according to size, scope, and global reach.
- 30 October 2012: Change – especially when change implies harmonisation, standardisation, and streamlining – can be a good thing. But when Europe’s Clinical Trials Directive was discussed at the recent TOPRA (The Organisation for Professionals in Regulatory Affairs) symposium the underlying theme was a lack of details.
- 23 October 2012: I know I promised more information on the FDA Promotional Materials guidance for Module 1 to be implemented next year, but there’s some breaking news: FDA has released draft guidance on e-submissions permitted for all medical device filings.
- 16 October 2012: The CSC Life Sciences Solutions U.S. Client Conference 2012 provided an invaluable opportunity for clients to share thoughts and opinions, as well as gain insights into CSC’s content management and regulatory products and services.