JUST ANNOUNCED: The Innovative Regulatory Pathways Summit
Wednesday September 27th, 2017
The Innovative Regulatory Pathways Summit is taking place January 29–30, 2018 in Arlington, VA. This intimate summit will bring together leading regulatory experts and senior-level executives to discuss regulatory strategies to expedite drug development in the U.S., EU, and Japan. Download the brochure here to review the sessions and speakers featured at this event.
Breakthrough therapy designations and other expedited pathways encourage sponsors to increase communication and collaboration with the FDA. Expedited drug development options are also available globally in ICH countries through programs like PRIME and Sakigate. Understanding how to best utilize global regulatory options is imperative to make an informed decision about the best ways to accelerate drug development.
Our chairperson, Alejandro D. Ricart, M.D., Executive Medical Director, Oncology, Early Development Strategy and Innovation at Novartis, will be discussing breakthrough therapy designations in Oncology. Here is what you can expect from Dr. Ricart’s session:
- Provide safe and effective novel oncology drugs to market quickly for life-threatening diseases and unmet needs
- Identify the importance of clinical trial design and clinical setting: Pivotal study vs. confirmatory study for BTD
- Discuss surrogate endpoints, well-established surrogate endpoints, and endpoints that reflect patient benefit
- Understand concern over the timely conduct of postmarketing-study commitment
Usha Ramesh, Ph.D., PMP, Executive Director, Regulatory Affairs, CMC, Pharmacyclics, an AbbVie Company, will be discussing her expertise with strategies to harmonize manufacturing readiness plans with accelerated drug development.
Download the brochure here to review the sessions and leading regulatory experts who are speaking at this event.
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