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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.
CPhI’s Pharma water Conference 2016 is a first of its kind platform for the pharmaceutical manufacturers and solution providers to network and discuss the major challenges around pharmaceutical water systems and brainstorm ways by which the industry meets the pharmacopeia requirements. This focused gathering strives to discuss strategies to produce and use high quality water for the manufacture of pharmaceuticals while ensuring no contamination in the pharmaceutical product or equipment
The main objective of this conference is to educate the attendees with the latest water solution technologies and understand the international methods and techniques to maintain high quality pharmaceutical water
Thanks to sponsoring from Nvidia two GPUs will be awarded to the best contributed talk and poster. Amazon EC2 will also be used during the workshop.
The high arithmetic performance of recent GPUs offers an important technological advance for molecular dynamics simulations but real benefits are only apparent if thousands of simulations are used, i.e. high-throughput. Environments like HTMD are designed to get the scientist to focus on the science and applications, rather than the technicalities.
This workshop is a great opportunity for industrial partners to get an overview of the state-of-the-art in molecular simulations for medicinal chemistry and drug design.
We look forward to welcoming you in Singapore in 2016!
In line with the current industry trends, the flagship event this year focuses on the discovery, development and clinical development of biomarkers in Autoimmune, Immuno-oncology, Neuroscience, Oncology as well as Cardiovascular, Rheumatology, COPD, Rare Diseases and Microbiome. Our expert speakers will also cover innovations in Biomarker research such as imaging biomarkers and assay development, big data challenges in biomarker research, new advances in biomarker technologies and platforms; insights into the human proteome atlas, population genetics, systems biology and their implications in Biomarker development. Do not miss out on gaining insights on the role of biomarkers in clinical development, clinical trials and clinical diagnostics.
This Zing conference will focus attention on key advances in both fields with the aim at fostering discussions between antibody experts and complement experts.
For the forthcoming conference, we will be continuing with debates as well as adhering to the format of the previous conferences which are designed to provide an in-depth progress report on new antiepileptic drugs in various stages of development, as well as to present new findings on second-generation treatments.
Last updated: 22 September 2016