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RAPS' Latest | 09 September 2014 | By Alexander Gaffney, RAC
Later this month, 2,000 regulatory professionals will descend on Austin, TX for RAPS’ 23rd annual Regulatory Convergence. As in past years, the conference will feature hundreds of the world's top regulatory officials in dozens of unique and exciting sessions designed to give attendees the tools they need to do their jobs better.
Among these sessions are some that stand out to me, your Regulatory Focus editor, as particularly exciting—sessions that cover important topics, emerging trends, new developments and the critical aspects of actually being a regulatory professional.
Here's my take on 10 of the many can't-miss sessions being held at 2014 RAPS this year.
3D Printing, also known as additive manufacturing, is shaping up to be one of the hottest issues in regulatory, and it's already having an impact on the life sciences industry. In August 2014, FDA cleared a 3D-printed skull, and the agency has indicated it is deeply interested in the issue. In September 2013 FDA regulator Jeffery Shuren indicated that the Center for Devices and Radiological Health (CDRH) plans to issue a 3D printing guidance by 2016. Since then, FDA has also said it wants its regulators to get training on 3D printing and has called for industry input into the regulation of 3D printing.
And that's just the medical device aspects. 3D printing also holds the potential to drastically shake up the biotechnology and pharmaceutical sectors, shrinking down once-massive manufacturing operations to a scale far more easily obtainable—and transportable. ( More here)
The 3D printing session at 2014 RAPS will explore 3D bio printing from the perspective of two professionals who are actively working in this emerging and exciting space. ( Check out more information about the session here).
Biosimilars are, and have been for a while, one of the hottest regulatory topics at FDA. How will FDA regulate them? What will it name them? How can the products get to market? When will these products first arrive on the market in the US?
But there's another topic which hasn't received quite as much attention: How can companies extrapolate biosimilar indications? This session, featuring top regulators from FDA, Health Canada and the European Medicines Agency (EMA), will examine case studies and present "agency perspectives" on the extrapolation of indications. For the biosimilars crowd, this is session is a must. ( Check out more information about the session here).
Regulatory intelligence is a big focus here at RAPS. Each morning we gather up as much regulatory information, analysis and insight as we can, packaging it into our signature Regulatory Intelligenceproduct. And beyond that, we are constantly digging into as many regulatory topics as we can, trying to make sense of what happened, why it happened and what it means for regulators.
The 2014 RAPS session on communicating actionable regulatory intelligence will cover the nuances of finding information and communicating it to stakeholders when and how they need it most. I am especially excited for this one as I will be a participating panelist alongside some highly experienced regulatory intelligence professionals. ( Check out more information about the session here).
It's tough enough to be a regulatory professional in a large organization, where you might have dozens of other team members to help work on new product submissions and filing. But what happens when you're a member of a start-up company with a total staff of just a few dozen?
This session, chaired by the esteemed Bob Yocher, RAC, FRAPS, will cover how to formulate a regulatory strategy, the unique challenges faced by regulatory professionals operating in a start-up environment, and how to succeed in a resource-poor environment where regulatory success is critical to organizational success. ( Check out more information about the session here).
Top regulators from Singapore, Indonesia and Malaysia will all be in attendance for an all-star session explaining the broad-ranging implications of the ASEAN Medical Device Directives (AMDD), which are set to go into effect in 2015. ( Check out more information about the session here).
FDA has released no shortage of ground-breaking policies this year, including two of particular note. The first, on so-called "research use only" (RUO) devices, made major changes relative to an earlier draft guidance regarding how RUO in vitro diagnostic devices could be labeled. And most recently, FDA issued a landmark ( and highly controversial) advanced draft guidance document on lab-developed tests seeking to bring the tests under a regulatory framework similar to that for IVDs.
In the meantime, companies marketing either of these types of products are left with a considerable degree of uncertainty. This 2014 RAPS session, with attendance from FDA's Director of the Office of In Vitro Diagnostics, Alberto Gutierrez, will seek to answer questions, dispel myths and chart out potential problems. ( Check out more information about the session here).
The International Medicines Device Regulators Forum (IMDRF) is shaping into an ambitious regulatory harmonization group, and perhaps no effort is emerging from it more quickly than its MDSAP proposal, which seeks to harmonize regulatory inspections across different regions. FDA is already in the midst of trying to build the MDSAP system, and IMDRF has already released several details about how the program is set to work, including the " grade assessment" system it will use and competency requirements for inspectors.
This notable session at 2014 RAPS will see an assembly of top regulatory officials, including a presentation by FDA's Kim Trautman, the IMDRF official charged with leading the project. The topic of discussion: What will this program look like in the near future, and what will regulators need to do to stay in compliance? ( Check out more information about the session here).
There's been no shortage of major clinical trial news coming out of the EU these last two years, and 2014 RAPS is set to examine two of the largest changes in separate sessions, and others in a must-attend third session.
In the first session on the EU Clinical Trials Regulation, an EMA official will outline the importance of the regulation (set to come into effect in 2016), what changes are set to occur, and how companies can prepare for the regulation's implementation. ( Check out more information about the session here).
The second of these sessions—on the potential impact of the EU Medical Device Regulation—is set to examine similar topics with the help of some of the EU's top regulatory experts and the European Commission's Erik Hansson. ( Check out more information about the session here).
Three of EMA's senior regulatory officials will be in attendance for this must-attend session discussing EMA's current and future objectives, priorities and changes. If you have any dealings with EMA, or plan on having dealings with EMA in the near future, this is one session that should be on your list.
The 2014 RAPS: The Regulatory Convergence will take place in Austin, TX, from 27 September-1 October 2014. You can register for the conference online here, find out more about the conference sessions here, ways to make the most of your conference experience here, and the conference here.
10 More Sessions We Can't Wait to Attend