$2,085

2nd eRegulatory Submissions Summit (exl) AS

Event Information

Share this event

Date and Time

Location

Location

Philadelphia

Philadelphia, PA

View Map

Refund Policy

Refund Policy

No Refunds

Friends Who Are Going
Event description

Description

Regulatory submissions landscape has been confronting with many evolving regulatory changes, trends and challenges and it’s important that regulatory professionals properly manage submissions. The regulatory submissions process can quickly become challenging when multiple team members are involved, and it is essential to ensure the quality and consistency of each document included in a submission.

The 2nd eRegulatory Submissions Summit will cover electronic submission processes and protocols for constructing strategies for IDMP, RIM, global and regulatory submissions. This summit will also address regulatory information management experiences and the proposed new standards for the identification of medicinal products and best practices for eCTD submission requirements.

2017 Audience Breakdown by Seniority Level:

Top Five Reasons to Attend

  1. Review EDMS Implementation for eCTD system
  2. Discuss submission management, regulatory project management, agency interactions, and time to market strategies
  3. Understand latest developments in ISO IDMP standards
  4. Gain a better understanding of the complexity of publishing eCTD
  5. Explore global and regulatory eCTD management and requirements

Who Should Attend

This conference is specifically designed for pharma, biotech and med device professionals responsible for:

  • Regulatory Affairs
  • Regulatory Writing/Medical Writing/Publishing/Information/Submissions
  • Document and eRecords Management
  • IDMP
  • Business Operations/Processing
  • Labeling
  • Clinical Trials Management/Data
  • Clinical Data
  • Outsourcing/Clinical Outsourcing/Vendor Management
  • Product Development
  • Quality Assurance/Quality Control

This event is also of interest to:

  • CROs
  • Regulatory Specialists
  • Regulatory Publishing/Regulatory Submission Software Designers



Featured Speakers


Adam Ivans, Submission Manager, BRISTOL-MYERS SQUIBB
Alexis Harper, Global Head of Submission Portfolio Management, UCB
Marc Stern, Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS

S. Albert Edwards, President, S. ALBERT EDWARDS, PHARMD, LTD; Founder, ESUBMISSIONS UNIVERSITY



Partners


MEDtube

MEDtube is an innovative video education platform for health professionals. It allows sharing videos and other materials with a community of more than 110,000 users worldwide, as well as building e-learning courses. The videoteque is updated daily and now contains almost 15,000 videos.

Website: http://MEDtube.net

PharmaLeaders

PharmaLeaders.com is an online environment dedicated to enriching the careers of more than 200,000 life sciences professionals. With breaking news and informative content grouped into one of nine segmented channels, in-depth special reports, job and events postings, and so much more, industry executives, manufacturers, marketers and educators can count on PharmaLeaders for the tools they need to succeed in today’s competitive market environment. For more information, visit us online at www.pharmaleaders.com, write to us at info@pharmaleaders.com or call 888-400-1573, ext. 240.

Website: http://pharmaleaders.com/

pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing together healthcare through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.

Visit pharmaphorum today to share, discuss and debate: www.pharmaphorum.com

Website: http://www.pharmaphorum.com

PharmaVOICE

PharmaVOICE magazine, reaches more than 41,000 qualified subscribers and 100,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics, and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.

Website: http://www.pharmavoice.com

PM360

PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal’s targeted and insightful editorial focuses on issues that directly impact critical decision making, including: planning and implementation of cutting edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the ‘360’ in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.

Website: http://www.pm360online.com/

Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.

Website: http://www.TechnologyNetworks.com

Please contact the event manager Marilyn (marilyn.b.turner(at)nyeventslist.com ) below for:
- Discounts for multiple participants.
- Require a price quotation.
- Require to pay by wire transfer or PayPal
- Invitation letter for visa applications

NO REFUNDS ALLOWED ON REGISTRATIONS
-----------------------------------------------------------------
This Event is Brought to You by:
EXL Events Inc - NewYorkEventsList
http://www.NyEventsList.com
http://www.BostonEventsList.com
http://www.SFBayEventsList.com

MYL171024CEV

Share with friends

Date and Time

Location

Philadelphia

Philadelphia, PA

View Map

Refund Policy

No Refunds

Save This Event

Event Saved