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Presented by the University of Missouri-Kansas City School of Nursing and Health Studies
Considering the need to address this challenge, CPhI is announcing the first ever specialised training on cGMP taking place in September at Mumbai. This two day exclusive training will be conducted by Former US F.D.A trainer who would help companies to prevent instances of contamination, mix-ups, deviations, failures and errors to successfully meet the desired quality standards.
FDA meetings are undeniably one of the most important steps in the development of medicinal products. Whether you are developing a drug, biological product, medical device, generic, diagnostic or anything else regulated by the FDA, it is a good idea to get direct feedback from the FDA about their concerns regarding your product before embarking on expensive and time-consuming development steps. FDA meetings need to be included in all product development strategies. However, the best answers are the one obtained by asking the best questions. Not only the best questions but the conduct of the meeting, management of time, efficiency of response, careful consideration of the answers, all could lead to successful conclusion to the meeting. This workshop would discuss the what, who, when and how of the FDA meetings. Steps from requesting a meeting, preparing and submission of the information package, preparing for the meeting, the conduct of the meeting and follow-up will be discussed using real-life experience and case studies.
Despite a few guidance documents to help sponsors prepare for meetings with the FDA, it is a challenge to understand the most efficient and productive ways to strategize, prepare, conduct, and follow-up for these meetings. There are many misconceptions about the expectations from these meetings both for the sponsor and the FDA, and hence many sponsors fail to get the most benefit from them. Over the years, the FDA has also revised processes and practices for meeting with sponsors.
This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA. Throughout the workshop, the author will discuss case studies and examples to highlight the common errors and potential solutions. This workshop contains a collection of practical tips from the instructor’s extensive FDA meeting experience. This one-of-a-kind workshop will provide step-by-step instructions and practical tips to the most productive meeting with FDA for all FDA-regulated organizations.
Understanding all kinds of FDA meetings for drugs, biologics, medical devices, and all FDA-regulated meetings
When to and not to do meetings with FDA
Creating, managing and defending rationale for meetings with FDA
Requesting process for FDA meetings
Creating a meeting information package and its regulatory requirements
Logistics of an FDA Meeting
Best practices for FDA meeting follow up
Who Will Benefit:
Regulatory affairs professionals
Senior management executives (CEO, COO, CFO, etc.)
Clinical trial specialists
Regulatory compliance associates and managers
People investing in FDA-regulated product development projects
The meeting will comprise a high quality programme of plenary lectures, plus both a poster session, and a commercial exhibition.
Uniting senior scientists from chemistry and biology, Discovery Informatics & Analytics 2016 offers inspirational keynote speeches, practical case studies offering immediate takeaways, interactive discussion sessions, and maximum opportunity to engage and network with colleagues from Europe and beyond.
We look forward to welcoming you in Singapore in 2016!
This Zing conference will focus attention on key advances in both fields with the aim at fostering discussions between antibody experts and complement experts.
Stand vom 19. August 2016