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Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

Event Details

Preparation of FDA Submissions and Communicating with the FDA | Seminar 2018

Time: June 20, 2018 at 9am to June 21, 2018 at 5pm
Location: Hilton Zurich Airport
Street: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
City/Town: 8152
Website or Map: https://www.globalcompliancep…
Phone: 800-447-9407
Event Type: seminar
Organized By: John Robinson
Latest Activity: Apr 26, 2018

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Event Description

Course "Preparation of FDA Submissions and Communicating with the FDA (INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, Post-Approval Supplements)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Why you should attend:

  • What do the regulations say?
  • Navigate the FDA drug and device approval system
  • Prepare, construct and submit well-written IND, NDA, BLA, PMA, 510(k) and IDE submissions and regulatory filings
  • Navigate the FDA review process
  • Identify the required regulations and guidance documents for drug and biologic submissions
  • Use regulations and guidance documents to outline and construct a variety of drug and biologic submissions
  • Formulate a working knowledge of regulatory submissions, publishing, and style guides
  • Create checklists that encompass timelines and sections needed from contributors
  • Strategic and technical guidance for drug and medical product development and regulatory review
  • Regulatory policy guidance
  • Regulatory Strategy planning and communications
  • FDA 510(k) submissions for obtaining FDA clearance

Location:  Zurich Switzerland Date: June 21st & 22nd, 2018 and Time: 9:00 AM to 5:00 PM

Venue:  Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland

 

Price:

Price: $1,695.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*

Register now and save $200. (Early Bird)

Until May 20, Early Bird Price: $1,295.00 From May 21 to June 18, Regular Price: $1,495.00

Sponsorship Program benefits for “Writing & Managing Effective SOPs” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship 

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901792SEMINAR?SEO

 

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanelindia/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

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