2nd eRegulatory Submissions Summit

Start Date : July 12, 2018
End Date : July 13, 2018
Time : 8:00 am to5:00 pm

Phone : 917-258-5158
Email : esternberg@exlevents.com

Location :
Sonesta Philadelphia Rittenhouse Square, 1800 Market Street, Philadelphia, 19103, United States

Website

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Description

The 2nd eRegulatory Submissions Summit will take place on July 12-13 in Philadelphia, PA, and you will hear experiences from

regulatory affair leaders who have adapted, operated and transformed into these regulations successfully. Don’t miss out on two days of reviewing format requirements, staying up to date with the industry, and current trends and challenges on eCTD, RIM, IDMP, and global submissions.

 

Don’t miss out on these featured sessions:

. Strategic Planning for Submitting Master Files and Commercial Investigational New Drug Applications in eCTD Format

. Regulatory Perspective: Explore How to All Be on the Same Page, Including Vendors

. RIM/Records Management: Building Key RIM Partnerships and Changes in Records Policy

. EMA Announced the New Location, November 20, 2017, Netherlands — Explore the Impact of the Industry in Light of This

Announcement

. ANDA, CMC Criterion: Discuss Some of the Enhancements of CMC Filling Requirements in ANDA

 

Prices:

 

EARLY BIRD PRICING – Register by Friday, June 1, 2018: USD 1895

STANDARD PRICING – Register after Friday, June 1, 2018: USD 2095

ONSITE PRICING: USD 2195

 

URL:

 

Brochure: https://go.evvnt.com/209158-0?pid=3506

 

Speakers: Olga Alfieri, Marc Stern, Michael Hellerstein, Deborah Satoh, Alexis Harper, Daniel Capion, Thomas Noto

Registration Info

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Event Categories: Health & Nutrition and Internal Medicine.

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