European Changes in Regulatory Environment at LORENZ userBridge
From the first shot of espresso in the morning to the last bottle of Barolo at night, this year’s LORENZ userBridge is another winner. Held in the wonderful city of Turin (Torino), Italy the nearly 150 attendees – more than attended last year's twenty-fifth anniversary event – have enjoyed fantastic weather when not attending informative sessions held at the Starhotels Majestic - a suitably romantic venue, given that I have my wife as my traveling companion on this trip (right).
There have been many opportunities during this two-and-a-half-day event to learn about changes in the industry and about Lorenz’s product plans, as well as best practices related to submissions.
Among these was my presentation titled ‘Populating your eCTD - Submission Document Rendering." Follow-up discussions have so far been focused on life sciences requirements like removing same-page hyperlinks from PDFs rendered from source documents.
This seemingly minor detail is an example of the level of rigor this industry puts on generating the highest quality output to ensure the PDF content can be easily navigated by regulatory reviewers (e.g. FDA) on the way to getting a submission approved (and therefore a product to market).
Other informative sessions related to changes in the regulatory environment including AMNOG in Germany, and the future of RPS (Regulated Product Submissions) as the replacement for eCTD as the submission format.
AMNOG is unique to Germany; it is an attempt to lower overall health costs for a population by placing restrictions on new incoming drugs/substances. I have heard that AMNOG essentially requires any company trying to introduce a new substance into Germany – where a similar one already exists – to demonstrate that it is more effective than the incumbent, or else they are unable to charge more. Other countries have similar concerns regarding spiralling drug costs.
The implication on sponsor companies is that they have to be very deliberate and cautious when attempting to enter a new market – this means lots of documentation. The efficiencies and control offered by software solutions like Lorenz can help manage the inevitable costs associated with all of that submission documentation.
Finally, RPS is expected to come up for ballot this month and we learned at the Lorenz event that anticipation grows around late 2013 or early 2014 as the time-period when RPS will be accepted as a format by the FDA. For now this is still speculation but with the long development times for new substances people in this industry will need to start planning for the necessary changes to their systems.
I’m looking forward to learning more about the industry at the event and more about Italy from the wonderful city of Turin, touring such spectacles as the Mole Antonelliana (right).