FEATURED SPEAKERS: SPECIAL FOCUS

IDMP Update on the new planning strategies for ISO IDMP

Standards Preparing for IDMP Compliance — What you need to know,

What is IDMP? How to plan for IDMP

Global Submissions Review different requirements across regions (U.S., EU,

Canada) and explore some of the key challenges Understand how EU and U.S. dossiers can be reused for

emerging market submissions Study international submissions, streamline and process,

understand the validation, why is it not clear

Regulatory Information Management Learn some of the changes in regulations and the impact in

the RIM business Gather submission management, regulatory, project

management, agency interactions, time-to-market strategies Keeping up with Regs, Technology, Data Management, Public

Perception

eCTD Streamline the implementation of eCTD and document

management Discuss Module 1and the life cycle of documentation How industry data is handled and how eCTDs are processed

“As a young professional, it is very informative and somewhat comforting to know that some of the problems I face as a company are actually industrywide.”

—Senior Regulatory Manager, KASHIV PHARMA

“Well put together and offered a lot of useful information.”—Submission Manager, BMS

eRegulatory SubmissionseRegulatory Submissions

Navigate the Regulatory Submission Landscape by Examining Regulatory Trends and Challenges for IDMP, RIM, Global and Regulatory Electronic Submissions SUMMIT

July 12-13, 2018The Sonesta Hotel | Philadelphia, PA2nd2nd

SPONSORS

CONFERENCE CHAIR Olga Alfieri,

Director, Global Submission Management, EISAI

Marc Stern, Director, Regulatory Processes, Operations, and Publishing, EAGLE PHARMACEUTICALS, INC.

Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX

Deborah Satoh, Head of CMC Regulatory Submission, SHIRE

Alexis Harper, Global Head of Submission Portfolio Management, UCB

Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS

Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS, INC

VENUE INFORMATIONSonesta Philadelphia Downtown Rittenhouse Square 1800 Market St. | Philadelphia, PA 19103

To make reservations, please call 1.800.SONESTA and request the negotiated rate for ExL’s July Meetings. You may also make reservations online using the following weblink: http://bit.ly/2n4J6CI. The group rate is available until June 20, 2018. Please book your room early, as rooms available at this rate are limited.

*ExL Events is not a affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, 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.

WHO SHOULD ATTENDThis 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

Publishing

Global Regulatory Operations

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

Dear Colleague,

When the eCTD submissions became mandatory by the FDA in 2015, life science organizations became confronted with many evolving regulatory changes, trends and challenges that came with these regulations. Regulatory submissions had to include all documentation submitted for review, and it became essential to ensure the quality of each document for the regulatory submission process. The Electronic Common Technical Document (eCTD) is an interface and international specification for the pharmaceutical industry that has improved the regulatory review processes and implementation of submissions.

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

8:00 Registration and Continental Breakfast

9:00 Chairperson’s Opening Remarks

Olga Alfieri, Director, Global Submission Management, EISAI

Managing eCTD Requirements and Tackling Current Trends and Challenges

9:15 Strategic Planning for Submitting Master Files and Commercial Investigational New Drug Applications in eCTD Format Discuss some of the new eCTD requirements for IND and for DMF

Outline how companies are complying with the May 5, 2018 deadline and how they were fully prepared

Understand how to reduce errors and the delaying process to approval

Study IND eCTDs production and delivery strategies

David Ross, Director, Global Regulatory Affairs, ASTRAZENECA

10:00 The Juggling Act of Implementing Electronic Submissions at a Small Company Assess deciding between in-house implementation and outsourcing in a small company, where many functions are already outsourced but budgets are lean and the do-it-yourself mentality is strong

Highlight juggling eCTD implementation with numerous non-regulatory responsibilities

Outline challenges, best practices, and my experience in achieving management buy-in

Hear experiences in interpreting the sometimes opaque guidance from FDA

Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX

10:45 Networking Break

11:15 Regulatory Sourcing in an Emerging Pharmaceutical Company Discuss strategic souring and review some sourcing examples

Explore how to all be on the same page including vendors Walk through some of the pros and cons, beneficial strategies, and pitfalls

Heather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

12:00 Document Production, Document Management, Regulatory Submission Management and Regulatory Information Management Reveal some of the challenges when transitioning from paper to electronic fillings

Clarify some of the new procedures for documentation and file management

Implement some of the key factors into eCTD publishing

Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS

12:45 Luncheon

1:45 Module 1: Future Expectations and Practical Implications for the Industry Verify the guidance for compiling an eCTD dossier Understand specifications for compiling and validating your eCTD regulatory activity

Address how the industry data handled and how eCTDs are being processed

Examine the new U.S. Module 1 V2/3 Refine some of the regulatory experiences and errors

Olga Alfieri, Director, Global Submission Management, EISAI

2:30 Implementing and Managing eCTD: Experiences, Solutions and Challenges Explore standardized and improved regulatory affairs processes; implemented SOPs and an electronic regulatory communications management systems

Include some of the experiences occurred in implementing a new eCTD system

Develop and implement regulatory strategies and understand how to manage, and monitor regulatory processes

Review some of the challenges with outsourced manufacturing projects

Study reports and tools for the preparation of eCTD and republishing eCTD

Alexis Harper, Global Head of Submission Portfolio Management, UCB

3:15 Networking Break

Touch on Identification of Medicinal Products and Master Regulatory Information Management

3:45 Submission Document and Publishing Systems Oversee some of the challenges experienced during the transition to a new RIM system

Identify how to message senior MGE on eSubmissions infrastructure tasks and outcomes

Manage keeping up with regs, technology, data management and public perception

Marc Stern, Director, Regulatory Processes, Operations, and Publishing, EAGLE PHARMACEUTICALS, INC.

4:30 RIM/Records Management: Building Key RIM Partnerships and Changes in Records Policy Review late document arrival, a problem that has arisen Explore data standards, more requirements are coming from FDA on pharm-tox and clinical on this — a need to work back into their organization for electronic submission people

Discuss Drug Master Files, new FDA deadline of May, 2018 and clarify the various difficulties facing this industry segment, potential litigation with FDA, long-term need to comply

Assess the cost of electronic publishing systems

S. Albert Edwards, President, S. ALBERT EDWARDS, PHARM.D., LTD

5:15 Day One Concludes

Thursday, July 12, 2018 | Day OneC

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8:00 Continental Breakfast

8:45 Chairperson’s Recap of Day One

Olga Alfieri, Director, Global Submission Management, EISAI

9:00 IDMP: Preparing for IDMP Compliance — What You Need to Know About IDMP? Evaluate ISO IDMP SPOR data domains and OMS/RMS implementation

Review FDA’s future with IDMP and eCTD mandates on U.S. applications

Understand how to approach IDMP master data management

Discuss the series of IDMP standards and understand the benefits to patients and the healthcare community

Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS

Global Submission Strategy and Planning

9:45 ANDA, CMC Criterion: Discuss Some of the Enhancements of CMC Filling Requirements in ANDA Master GDUFA metric goals to apply to the ANDA Ensure there is proper information for justification of impurity limits, per the ANDA Impurities Guidances

Review proper CMC submission and industry-specific challenges

Deborah Satoh, Head of CMC Regulatory Submission, SHIRE

10:30 Networking Break

11:00 AdPromo Submissions in eCTD Format Disscuss the process of submitting AdPromo in eCTD Hear challenges to changing from a legacy process Understand and gain AdPromo stakeholders perspective and why it is important

Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS, INC

11:45 Navigate With FDA’s New Requirements for eCTD Submissions and Managing Global Changes From eCTD Global Submissions Establish some of the emerging marketing submission for EU and U.S. Dossiers

Review some of the requirements and preparation of new countries adopting to eCTD

Discuss recent trends and best practices for successful eCTD submission

Address key challenges of electronic filling

ModeratorHeather Sinsel, Manager, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

12:15 Luncheon

1:15 EMA Announced the New Location, November 20, 2017, Netherlands — Explore the Impact of the Industry in Light of This Announcement Outline some of the changes that accompany this announcement

Evaluate some of the global dossier submission strategies that are occurring

Review how to submit and maintain an eCTD dossier throughout the life of a drug product

Specify regional differences

Olga Alfieri, Director, Global Submission Management, EISAI

2:15 Global Submission Latest Updates and Expectations of eCTD Navigate regulatory documents and discuss why they are getting rejected

Develop and implement process documents Discuss emerging markets, global access and marketing when the compound is submitted

Establish dossier requirements and country requirements Touch on changing evolving health authority regulations and how more countries are switching to eCTD but are experiencing confusion and conflicts

Discuss eCTD in other countries (South Africa and Canada)

Luke Everhart, Senior Specialist, Regulatory Operations and Submissions, INOVIO PHARMACEUTICALS

3:00 Conference Concludes

Friday, July 13, 2018 | Day Two

Media Partners

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“ As a young professional, it is very informative and somewhat comforting to know that some of the problems I face as a company are actually industry wide.”

—Senior Regulatory Manager, KASHIV PHARMA

Group Discount ProgramSave 25% per person when registering four

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Registration

Registration Fees for Attending ExL’s 2nd eRegulatory Submissions SummitEARLY BIRD PRICING — Register by Friday, June 1, 2018

Conference $1,895

STANDARD PRICING — Register After Friday, June 1, 2018

Conference $2,095

ONSITE PRICING Conference $2,195

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contact our offices at (201) 871-0474.

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eRegulatory SubmissionseRegulatory Submissions

July 12-13, 2018The Sonesta Hotel | Philadelphia, PA

Navigate the Regulatory Submission Landscape by Examining Regulatory Trends and Challenges for IDMP,

RIM, Global and Regulatory Electronic Submissions SUMMIT

FEATURED SPEAKERS:

CONFERENCE CHAIR Olga Alfieri, Director, Global

Submission Management, EISAI

Marc Stern, Director, Regulatory Processes, Operations, and Publishing, EAGLE PHARMACEUTICALS, INC.

Michael Hellerstein, Director, Regulatory Affairs and Quality Systems, GEOVAX

Deborah Satoh, Head of CMC Regulatory Submission, SHIRE

Alexis Harper, Global Head of Submission Portfolio Management, UCB

Daniel Capion, Director, Global Regulatory Operations, FERRING PHARMACEUTICALS

Thomas Noto, Senior Director, Regulatory Operations, LEXICON PHARMACEUTICALS, INC

SPECIAL FOCUSIDMP Global

SubmissionsRegulatory Information Management

eCTD

Update on the new planning strategies for ISO IDMP Standards

Preparing for IDMP Compliance — What you need to know, What is IDMP?

How to plan for IDMP

Review different requirements across regions (U.S., EU, Canada) and explore some of the key challenges

Understand how EU and U.S. dossiers can be reused for emerging market submissions

Study international submissions, streamline and process, understand the validation, why is it not clear

Learn some of the changes in regulations and the impact in the RIM business

Gather submission management, regulatory, project management, agency interactions, time-to-market strategies

Keeping up with Regs, Technology, Data Management, Public Perception

Streamline the implementation of eCTD and document management

Discuss Module 1and the life cycle of documentation

How industry data is handled and how eCTDs are being processed

2nd2nd

Please make checks payable to: “PMA"