Workshops/Seminars for Pharma, Diagnostics, and Medical Device Professionals
FDAMap's workshops and seminars include 14-16 hrs. of training, interactive sessions, complete training material, lunch, energy breaks, and networking opportunities with the trainer and other attendees. Speakers include experts in clinical trials, FDA regulatory affairs, FDA Compliance, data management, statistics, safety reporting, pharmacovigilance, social media marketing of medical products (drugs, biologics and medical devices), project management, GMP, GCP GLP, FDA/EMA audits, and information technology.
Upcoming Workshops:
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Electronic Submissions to the FDA: All About the eCTD
13-14 July 2015, Washington DC Hands-on training on creating electronic IND and NDA submissions and upload on the FDA's servers FDA's GMP Requirements for a New Drug Approval (NDA): Basics of the GMP Simplified
9-10 July 2015, Philadelphia PA Introduction to FDA requirements for GMP for drugs in late-stage clinical trials and NDA applications. Adaptive Clinical Trials
23-24 July 2015, Washington DC Understanding FDA’s and EMA’s current guidance and practical solutions in adaptive design trials SOPs for FDA Regulated Industry: Best Practices to Withstand FDA's Expectations
13-14 August 2015, Philadelphia PA Essential components of SOPs and methods to develop, maintain, manage, train and audit for SOP compliance Writing Technical Regulatory Documents
27-28 August 2015, Washington DC Practical tips and training in writing good quality regulatory documents for submission to FDA and other regulatory agencies |
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