| Date post: | 08-Aug-2015 |
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Healthcare |
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FDAMAPMaking Regulations Easy….
Workshops, Boot-camps and Conferences
A one stop source for training, education, and consultation about US FDA processes.
www.FDAMap.comEmail: [email protected]
410-501-577720203 Goshen Rd, Suite 261
Gaithersburg, MD 20879
WHO WE AREFDAMap is a group of experts in healthcare regulations, business, and public policy in the US, Europe, Asia, South America, and most other parts of the World with a collective experience of decades in each area. We strive to create awareness, education, professionalism, and success in all areas of compliance and quality.
We work with professionals, regulators, and government agencies to build unique platforms for consultation, training, networking, and professional development. We strive hard to make high quality, mutually beneficial relationships with our customers and partners alike.
SIMPLIFYING THINGS FOR YOU…We keep things simple and straight-forward, give equal attention to praise and criticism both, so that we continue doing the things meticulously we do well and improve where required. We aim to build better platforms for interactions for experts and novices, alike, enabling them to come together to learn, contribute, and make a difference.
OUR HISTORYWe started about 16 years ago in the Washington DC metropolitan area as a consulting enterprise and grew over the years to create first of its kind consultation portals. The FDAMap initiative is the newest venture of a group of leading experts from the industry and government to bring professionals at all levels together to create best practices based on logic, logistics, legal, and least-burdensome compliance.
OUR PANEL OF EXPERTS IN THE UPCOMING CONFERENCE IN ZÜRICH
Our panel of experts and speakers comprise of distinguished industry professionals, who are well known across the US and Europe for their expertise in
regulatory strategy, pharma, compliance, GMP and quality issues.
OUR SPECIALIZATIONTHOUGH WE SPECIALIZE AT MANY THINGS, BUT WE HAVE ACQUIRED GLOBAL REPUTATION FOR REGULATORY AND COMPLIANCE ISSUES, CLINICAL TRIALS,
SEEKING CONSULTATIONS AND PROVIDING EXPERT ADVICE FOR PHARMA PROFESSIONALS AND MANUFACTURERS.
Interactions with US FDA, Health Canada, EMA, Notified Bodies, KFDA, CFDA, and TGA, FDA meeting process, how to prepare for meetings with the FDA.
CURRENT GUIDELINES and from Healthcare regulatory agencies
Expert Advice, regulatory affairs and compliance training, regulatory compliance consulting, and regulatory strategy for medical products.
OUR UPCOMING CONFERENCE
Regulatory Consultations – Effective Interactions with US FDA in Comparison to European Authorities to Accelerate Global Drug Development
Regulatory Strategy Summit-I28-29 May 2015, Zurich, Switzerland
WHY YOU NEED TO ATTEND THIS CONFERENCE
It’s an opportunity to learn the agency’s perspectives on how to properly interact and what their expectations are during teleconferences and meetings
The speakers will provide examples and case studies of best practices as well as common pitfalls in industry-agency interactions resulting in delays and denials
Our panel of speakers includes experts, who are familiar with regulators’ perspective on adequate meetings
Encapsulated information at one place Step-by-step instructions on creating a meeting-information-
package / briefing book
We organize seminars and workshop for
Drugs, biologics, medical devices and
diagnostic kits developers, who are
planning to meet regulators or need tips on how to get the most out of a
meeting with regulators.
www.fdamap.com | 20203 Goshen Rd, Suite 261, Gaithersburg, MD 20879
Email: [email protected] | Phone: 410-501-5777 | (C) Copyright (2015) All Rights Reserved
For more information about our workshops and conferences in
your area, please contact us at:
