2 Day Seminar on Regulatory and Technical Writing for FDA-Regulated Industry

Description:

Regulatory professionals have to write highly technical documents for a variety of audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents covering anywhere from simple issues such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators.

Reasons to attend:

The trainers will provide practical tips using examples on how to organize and deliver information into clear and readable documents, and how to edit, format, present and publish technical regulatory documents for most favourable reception by the regulatory agencies. The workshop will also discussed rules for writing documents intended for electronic submission to regulatory agencies. This one-of-a-kind workshop will provide technical, practical, logical and logistical tips for regulatory writers of all levels of skills.
Target Audience:

Regulatory affairs professionals preparing IND, DMFs, NDAs and other submissions
Medical and Technical writers
Project Managers, Directors
Supervisors, and lead workers in Regulatory Affairs
Quality Assurance and Quality Control
IT professionals looking to make eCTD submissions

Seminar Price Tags :

$ 999 Seminar - Single registration (Earlybird Price)
*Earlybird price is valid till Sep-25-2014
Oct 02-03, 2014, Boston

$ 4796 Special - Group Discount; Register for 5 attendees
Oct 02-03, 2014, Boston
*Hurry! This option is limited and based on availability. Great savings on Group registration!!!

Speaker Biography : Mukesh Kumar

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia.

For More Details or Enrollment Or Registration :
Contact : complianzworld.com
Phone : +1-866-978-0800
Fax : +1-888-883-7697
E-mail ID : [email protected]
Seminar Website : http://complianzworld.com/SeminarDetails.aspx?TopicId=5&Cotn=1290&Sub=Technical-and-Regulatory-Writing-for-FDA-Regulated-Industry---2-Day-Seminar