eRegulatory Submissions

July 10-11, 2017 / Sheraton Philadelphia University City / Philadelphia, PA

Summit

2017

Understand the Electronic Submissions Process and Protocols for IDMP, RIM, Global and Regulatory Submissions

GLOBAL SUBMISSIONS

REGULATORY INFORMATION MANAGEMENT

ELECTRONIC REGULATORY SUBMISSIONS

IDENTIFICATION OF MEDICINAL PRODUCTS REGULATORY BUSINESS OPERATIONS

KEY OBJECTIVES• Understand the challenges that submitters encounter during the preparation,

filing and management of regulatory submissions• Explore the latest developments in ISO IDMP standards• Learn best practices for delivering a successful electronic submission• Discuss global eCTD management and requirements• Navigate the end-to-end process of document and submission management

Michael SauterSenior Director Regulatory Operations and Global Labeling MALLINCKRODT PHARMACEUTICALS

Adam IvansSubmission Manager BRISTOL-MYERS SQUIBB

Sameer ThaparAssistant Professor and Advisor, Drug Safety and PharmacovigilanceRUTGERS UNIVERSITY

Marc SternDirector, Regulatory Processes, Operations and Publishing EAGLE PHARMACEUTICALS

Stephanie Hughes Regulatory Submissions Management Associate TEVA

Linda ChongManager, Global Regulatory Operations CELGENE

Heather SinselManager, Regulatory Operations and SubmissionsINOVIO PHARMACEUTICALS

Sabrina GirtyVice President, Regulatory AffairsLYCERA

SPONSORED BY:

CONFERENCE CHAIR:

To register, call 201 871 0474

Olga AlfieriDirector, Global Submission ManagementEISAI

VENUE INFORMATIONSheraton Philadelphia University City / 3549 Chestnut St. / Philadelphia, PA To make reservations, please call 1-888-627-7070 and request the negotiated rate for ExL’s July Meetings. You may also make reservations online at http://bit.ly/2msoy3S. The group rate is available until June 23, 2017. Please book your room early, as rooms available at this rate are limited. *ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services(EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

SPONSORSHIP AND EXHIBITION OPPORTUNITIESDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs.

eRegulatory Submissions20

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SummitDear Colleague,Regulatory submissions are a key component of the final stages of clinical research and must be properly managed and documented. However, the regulatory submissions process can quickly become challenging when multiple team members are involved, and it is important 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.

ExL Events’ 2017 eRegulatory Submissions Summit, taking place July 10-11, 2017 at the Sheraton Philadelphia University City in Philadelphia, PA, 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. Don’t miss hearing from industry and regulatory leaders addressing the following topics:

• Regulatory submissions processes and best practices for documentmanagement

• Quality management of eCTD global and regulatory submissions• How to achieve a successful end-to-end RIM process• The latest developments in ISO IDMP standards and how to implement them

I look forward to welcoming you in Philadelphia this summer!

Sincerely,

Kelly Osmulski Bryon MainKelly Osmulski Conference Production Director ExL Events, a division of Questex, LLC

Bryon MainPresidentExL Events, a division of Questex, LLC

WHO SHOULD ATTEND: This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas: • Regulatory Affairs• Regulatory Operations• Regulatory Writing/Regulatory Publishing/

Regulatory Information• Submissions• Document and eRecords Management• IDMP• Labeling• Clinical Trial Management• Clinical Data• Outsourcing/Clinical Outsourcing• Vendor Management• Product Development• Quality Assurance/Quality Control

This conference is also of interest to: • Regulatory Publishing/Regulatory Submission

Software Designers• CROs• Regulatory Specialists

8:00 Registration and Continental Breakfast

8:45 Chairperson’s Opening RemarksOlga Alfieri, Director, Global Submission Management, EISAI

MANAGE eCTD REGULATORY SUBMISSIONS AND GUIDELINES

9:00 Improve Quality eCTD Submissions Standards and Processes for a Speedy Regulatory Review • Capitalize on submission standards and processes for

eCTD writing, publishing and submitting a document• Review the benefits of eCTD and the computer-based

tools and systems that allow regulators to reviewprocesses more efficiently

• Tackle the latest specifications in the FDA eCTDsubmission standards

• Understand eCTD guidances for NDAs, BLAs, ANDAsand safety report management

Stephanie Hughes, Regulatory Submissions Management Associate, TEVA

9:45 Manage the Life Cycle of Data Through eCTD to Properly Ensure All Components of a Submission • Learn best practices for how to properly document a

submission in eCTD format• Explain how to keep track of all dossier changes

throughout the life cycle of a product• Explore the regulations that deliver INDs in eCTD

formatAlexis Harper, Global Head of Submission Portfolio Management, UCB

10:30 Networking Break

11:00 Discuss How to Improve the Delivery of an Electronic Submission by Managing Regulatory Requirements • Study eCTD strategies and regulatory pathways

to manage the format of documents and dossiersthroughout the life cycle of a clinical trial

• Submit product information that is compliant withregulatory requirements

• Explore how to manage all components leading up tothe final submission

Adam Ivans, Submission Manager, BRISTOL-MYERS SQUIBB

11:45 Case Study: Lessons Learned from a Small Biotech Pharmaceutical Company Transitioning to Electronic Filings • Navigate the transition from paper to electronic filings• Learn a small company’s perspective on how to

manage the life cycle of submissions• Highlight key factors and considerations to account for

when moving to electronic filesHeather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

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

12:30 Luncheon

1:30 Panel: Submission Challenges from Authoring to Publishing • Review how authoring practices are key to improved

publishing of leafs via style guides, templates, macrosand more

• Determine how to support document managementand publishing systems during critical times from atechnical and a user perspective

• Examine publishing guidelines for components of asubmission written by a third party

• Identify common submission challengesMarc Stern, Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS

2:15 Understand the Various Approaches to IDMP to Implement New Methods for Pharmaceutical Products • Discuss the implementation of ISO IDMP standards• Explore the newest requirements outlined in the ISO

IDMP Standard• Share the latest developments in IDMP and best

practices related to data management strategiesSameer Thapar, Assistant Professor and Advisor, Drug Safety and Pharmacovigilance, RUTGERS UNIVERSITY

3:00 Networking Break

3:45 Centralized Data and Process Management Through the Keys to Structured Authoring Success • Learn how data, processes and systems determine

your future resource needs• Solve process and data challenges before selecting

structured authoring tools• Remove low-level tasks from your high-value resources• Gain an understanding of how information automation

is possibleJack Yeager, CEO, SYLOGENT

4:15 Perspectives on Experiences Gained from Originating a Novel RIM System• Identify the real “R” in RIM: Is it Regulatory or Records?• Delve into the key business outcomes of a successful

RIM• Navigate the challenges of RIM acceptance and

funding• Examine the principles linking eCTD, RIM and the FDA

for senior management• Focus on a RIM’s role in audits and inspectionsS. Albert Edwards, President, S. ALBERT EDWARDS, PHARMD, LTD; Founder, ESUBMISSIONS UNIVERSITY

5:00 Day One Concludes

Monday, July 10, 2017 Main Conference, Day One

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8:00 Continental Breakfast

8:45 Chairperson’s Recap of Day OneOlga Alfieri, Director, Global Submission Management, EISAI

GLOBAL eCTD MANAGEMENT AND SUBMISSION STRATEGIES

9:00 Understand the Challenges Professionals Encounter During the Preparation, Filing and Management of Regulatory Submissions • Learn about and gather regulatory submission

intelligence experiences• Strategize regulatory submissions for IND, NDA and

global submissions• Focus on the developments in the global perspective

and submissions intelligenceOlga Alfieri, Director, Global Submission Management, EISAI

9:45 Regulatory Oversight on Global Clinical Trial Application Submissions• Share the challenges of regulatory oversight when

multiple CROs are involved• Describe the development of a clinical trial application

(CTA) content plan• Identify the systems CROs and sponsors use, and each

stakeholder’s needs• Implement regulatory compliance guidelines and CRO

CTA objectivesLinda Chong, Manager, Global Regulatory Operations, CELGENE

10:30 Networking Break

11:00 Utilization of Regulatory Information Management from Application to Registration• Develop and track RIM timelines for international

submissions• Establish how to best store critical information from

countries, including certificate of pharmaceuticalproduct (CPP) needs for dossier formats, dossiercontent and ancillary documents

• Assemble the dossier to better document thedevelopment and delivery of a submission

• Review the stages of an NDA/MAA from its inceptionto approval

Catherine Burgess, Senior Director, Emerging Markets Regulatory Affairs and Global Regulatory Affairs, TAKEDA

11:45 Panel: Explore Global eCTD Management and Requirements for Delivering Submission Files • Understand the latest developments and lessons

learned from each submission• Examine the updated EMA requirements for a

successful eCTD submission upload, includingrequirements for delivery files and submission units

• Discuss the implications of cloning the EU submissionfor other countries, such as Saudi Arabia and Oman

Linda Chong, Manager, Global Regulatory Operations, CELGENEAdam Ivans, Submission Manager, BRISTOL-MYERS SQUIBBAlexis Harper, Global Head of Submission Portfolio Management, UCB

12:45 Luncheon

1:30 Global Clinical Trial Application Submission Strategies to Better Track Regulatory Submissions and CTA Processes• Determine the most effective tactics for

communicating with CROs• Navigate the status of concurrent applications with

health authorities• Recognize the impact of protocol amendments and

other revisions during a trial’s start-up• Delve into lessons learned from a small pharma

company’s experience with the submission processSabrina Girty, Vice President, Regulatory Affairs, LYCERA Shelly Grasse, Regulatory Administrator, LYCERA

2:15 Regulatory Operations/RIM Change Management in the Continuous World of Organizational and Business Changes• Analyze the changes, acquisitions, mergers and the

process of downsizing that the industry is goingthrough

• Highlight changes in the transfer or exchange of data,including paper and electronic records and documents

• Explore the experiences of regulatory operationsprofessionals when dealing with data transfers andRIM

Michael Sauter, Senior Director Regulatory Operations and Global Labeling, MALLINCKRODT PHARMACEUTICALS

3:00 Conference Concludes

Tuesday, July 11, 2017 Main Conference, Day Two

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“Great overview and sessions on key new areas!”—Executive Director, Clinical Operations, ACORDA THERAPEUTICS

“Outstanding presentations, good engagement and excellent information!”

—TMF Process Owner, Clinical Operations, NOVO NORDISK

What Attendees Are Saying About ExL Conferences:

Questions? Comments? Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader?

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Registration Information

Media Partners

36OPMTHE FULL SPECTRUM OF PRODUCT MANAGEMENT

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Registration Fees for Attending ExL’s eRegulatory Submissions Summit

EARLY BIRD PRICING — Register by Friday, May 26, 2017 $1,895

STANDARD PRICING — Register after Friday, May 26, 2017 $2,095

ONSITE PRICING $2,195

Group Discount ProgramOffers may not be combined. Early bird rates do not apply. To find out more about how you can take advantage of these group discounts, please call 201 871 0474.

Save 25% per person when registering four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time). This is a savings of 25% per person.

Save 15% per person when registering three Can only send three? You can still save 15% off of every registration.

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CONFERENCE CODE: C930

eRegulatory Submissions

July 10-11, 2017 / Sheraton Philadelphia University City / Philadelphia, PA

Summit

2017

Understand the Electronic Submissions Process and Protocols for IDMP, RIM, Global and Regulatory Submissions

GLOBAL SUBMISSIONS

REGULATORY INFORMATION MANAGEMENT

ELECTRONIC REGULATORY SUBMISSIONS

IDENTIFICATION OF MEDICINAL PRODUCTS REGULATORY BUSINESS OPERATIONS

Linda ChongManager, Global Regulatory Operations CELGENE

Marc SternDirector, Regulatory Processes, Operations and Publishing EAGLE PHARMACEUTICALS

Stephanie Hughes Regulatory Submissions Management Associate TEVA

Heather SinselManager, Regulatory Operations and SubmissionsINOVIO PHARMACEUTICALS

Sabrina GirtyVice President, Regulatory AffairsLYCERA

Michael SauterSenior Director Regulatory Operations and Global Labeling MALLINCKRODT PHARMACEUTICALS

Adam IvansSubmission Manager BRISTOL-MYERS SQUIBB

Sameer ThaparAssistant Professor and Advisor, Drug Safety and PharmacovigilanceRUTGERS UNIVERSITY