No matter how relevant the learning sessions, it’s hard being out of the office and away from home. This year, we’re packing more great content and networking into less time. That means more time for the things that matter most to you.
The breakthrough therapy designation (BTD) was introduced in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) with an intention to foster innovation for the development of drugs indicated for serious or life threatening diseases or conditions. Ten of the 45 new drugs approved by the FDA in 2015 received BTD. The total number of requests, grant of status, and approvals of BTD increase every year. In early 2016 the European Medicines Agency (EMA) adopted the Priority Medicines (PRIME) scheme. PRIME is being compared to the FDA’s BTD, which speeds up the review process for specific drugs that address serious unmet medical needs. This session will review case studies, breakdown the background of BTD and tackle the pros and cons of EMA PRIME.
Get a breakdown of the new European legislation for clinical trials with pharmaceuticals and find out how the various stakeholders are preparing for the new procedures. The status of implementation of the various requirements into national procedures will be presented. The impact of the upcoming legislative changes from the perspective of US-based organizations will be discussed. Our panel will share their experiences to date and will make practical recommendations on how and when to implement the necessary changes within your organization.
Join us for an in-depth look at the history of global labeling alignment over the past several years and the industry trends for the future. We’ll review the regulations and challenges related to maintaining identical safety content between generic and branded labels. Plus, assess the magnitude of inconsistencies of product labeling safety changes in leading products across major markets.
There are currently 19 Alzheimer’s drugs in Phase III clinical trials, and 17 treatments could launch in the next five years. Patients and caregivers could witness unprecedented innovation in Alzheimer’s disease treatment development. Many conversations about the regulatory environment focus on the state of play in Alzheimer’s without drawing applicable lessons from other disease areas. Not this conversation. Our panel will not only address issues facing the Alzheimer’s treatment regulatory pathway, but also apply best practices and teachings from disease areas that have already improved their regulatory environments.
Over the past decade, regulatory legislations for drug development in pediatric patients were passed worldwide, dramatically increasing the number of drugs tested in and labeled for children. This session will speak to various initiatives and updates including the new guidance prepared by the Pediatric Study Plan Working Group. Our panelists will also highlight respective challenges and caveats of the Pediatric Rare Disease Priority Review Voucher (PRV) and the new funding initiative for the EU Horizon 2020.
With the pharmaceutical industry rapidly adapting their business models in the Asia Pacific region, a growing list of regulatory requirements and expectations are imposing new challenges to regulatory affairs professionals. We’ll face these challenges head on in this session, and provide you guidance on creating a strategy, process and timeline with special considerations and local requirements for drug product registration.
Orphan drug designations and approvals have shown impressive growth annually over the past 15 years. Join us as we take a look at the newest initiatives to maintain productivity in the US, EU and Japan. Our panelists will also highlight respective challenges and caveats of exclusivities in this growing area of development.
The landscape in drug development and for getting a drug to market is changing. In this session, we will discuss solutions for successful stakeholder interactions during drug development, namely on how value translates from R&D to market and ultimately patients. We’ll critically look at the challenges posed by expedited pathway schemes from the payers’ perspective and how the need for earlier patient access further complicates the drug development considerations. You will also learn how to develop a realistic roadmap for the development of a therapeutically and commercially successful drug.
Biosimilars have made a big impact on drug prescription choice. Biosimilars are officially approved versions of original biologic “innovator” products. Since they are not identical, they are not interchangeable. The EU has been approving them for years, and now the US is addressing requirements. This session will discuss the impact on the marketplace, how the FDA will define interchangibility with reference drugs and outline lessons learned after shortcuts of guidelines led to problems with biosimilar programs.
At the Convergence, attendees can engage in a variety of sessions that cover multiple areas of focus within the regulatory world. The following program tracks are available this year:
Key Topics to Include:
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