New York Professional Events List


eRegulatory Submissions Summit


Date
Jul 10, 2017 - 08:00 AM - Jul 11, 05:00 PM
Organizer
exlevents
Location
Sheraton Philadelphia University City Hotel 3549 Chestnut Street Philadelphia, PA 19104,

Philadelphia,
PA ,
US,
ZIP: 19104
Phone: +1 929 900 1853

eRegulatory Submissions Summit

eRegulatory Submissions Summit

Regulatory submissions are critical in clinical research 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. Doing so from the earliest stages of a product’s development benefits your organization.

The 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. Come hear the latest guidelines on eCTD and how to successfully submit an electronic submission.

Top Five Reasons to Attend

  1. Understand the challenges that submitters encounter during the preparation, filing and management of regulatory submissions
  2. Explore the latest developments in ISO IDMP standards
  3. Learn best practices for delivering a successful electronic submission
  4. Discuss global eCTD management and requirements
  5. Navigate the end-to-end process of document and submission management

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
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Please contact the event manager Marilyn below for the following:
 
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
 
Event Manager Contact:


marilyn.b.turner(at)nyeventslist.com or Contact:  +1 929 900 1853
 
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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This Event Listing is Promoted by  New York Media Technologies LLC in association
with EXL Events Inc.

 
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Agenda


Day One

 Monday, July 10, 2017

8:00AM – 8:45AM
Registration and Continental Breakfast
8:45AM – 9:00AM
Chairperson's Opening Remarks
Olga Alfieri, Director, Global Submission Management, EISAI

 MANAGE eCTD REGULATORY SUBMISSIONS AND GUIDELINES

9:00AM – 9:45AM
Quality eCTD Submissions Standards and Processes for a Speedy Regulatory Review
Stephanie Hughes, Regulatory Submissions Management Associate, TEVA
9:45AM – 10:30AM
Manage the Life Cycle of Data Through eCTD to Properly Ensure All Components of a Submission
Alexis Harper, Global Head of Submission Portfolio Management, UCB
10:30AM – 11:00AM
Networking Break
11:00AM – 11:45AM
Discuss How to Improve the Delivery of an Electronic Submission by Managing Regulatory Requirements
Adam Ivans, Submission Manager, BRISTOL-MYERS SQUIBB
11:45AM – 12:30PM
Case Study: Lessons Learned from a Small Biotech Pharmaceutical Company Transitioning to Electronic Filings
Heather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

 REGULATORY INFORMATION MANAGEMENT GUIDELINES AND BEST PRACTICES FOR THE IDENTIFICATION OF MEDICINAL PRODUCTS

12:30PM – 1:30PM
Luncheon
1:30PM – 2:15PM
Panel: Submission Challenges from Authoring to Publishing
Marc Stern, Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS
2:15PM – 3:00PM
Understand the Various Approaches to IDMP to Implement New Methods for Pharmaceutical Products
Sameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance,RUTGERS UNIVERSITY
3:00PM – 3:45PM
Networking Break
3:45PM – 4:15PM
Centralized Data and Process Management – the Key to Structured Authoring Success
Jack Yeager, CEO, SYLOGENT
4:15PM – 5:00PM
Perspectives on Experiences Gained from Originating a Novel RIM System
S. Albert Edwards, President, S. ALBERT EDWARDS, PHARMD, LTDFounder, ESUBMISSIONS UNIVERSITY
5:00PM –
Day One Concludes
 

Day Two

 Tuesday, July 11, 2017

8:00AM – 8:45AM
Continental Breakfast
8:45AM – 9:00AM
Chairperson's Recap of Day One
Olga Alfieri, Director, Global Submission Management, EISAI

 GLOBAL eCTD MANAGEMENT AND SUBMISSION STRATEGIES

9:00AM – 9:45AM
Understand the Challenges Professionals Encounter During the Preparation, Filing and Management of Regulatory Submissions
Olga Alfieri, Director, Global Submission Management, EISAI
9:45AM – 10:30AM
Regulatory Oversight on Global Clinical Trial Application Submissions
Linda Chong, Manager, Global Regulatory Operations, CELGENE
10:30AM – 11:00AM
Networking Break
11:00AM – 11:45AM
Utilization of Regulatory Information Management from Application to Registration
Catherine Burgess, Senior Director, Emerging Markets Regulatory Affairs and Global Regulatory Affairs, TAKEDA
11:45AM – 12:45PM
Panel: Explore Global eCTD Management and Requirements for Delivering Submission Files
Linda Chong, Manager, Global Regulatory Operations, CELGENE
Adam Ivans, Submission Manager, BRISTOL-MYERS SQUIBB
Alexis Harper, Global Head of Submission Portfolio Management, UCB
12:45PM – 1:30PM
Luncheon
1:30PM – 2:15PM
Global Clinical Trial Application Submission Strategies and Status to Better Track Regulatory Submissions and CTA Processes
Sabrina Girty, Vice President, Regulatory Affairs, LYCERA
Shelly Grasse, Regulatory Affairs Specialist, LYCERA
2:15PM – 3:00PM
Regulatory Operations/RIM Change Management in the Continuous World of Organizational and Business Changes
Michael Sauter, Senior Director Regulatory Operations and Global Labeling, MALLINCKRODT PHARMACEUTICALS
3:00PM –
Conference Concludes
 

 


Speaker Details


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Event Categories
BUSINESS & MANAGEMENT CONFERENCES
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Keywords: fun, business , Clinical , conference , design , Designer, development , Fun , learn, Management




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