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DAY 1 | Monday, April 7th

9:00am-1:00pmCarranza - Ballroom Level

7:00-10:00pmNavarro Prefunction

8:00-9:00amHidalgo - Ballroom Level

8:00am-4:00pm

5:00pm

12:00pm

The Test Lab is Open - Appointments are availableOur Solution Consultants will answer questions and discuss specific needs/functionality, while providing assistance and facilitating demos on different modules of software. This includes the entire LIQUENT InSight® platform.

Our Client Enablement team will also be available for assistance. Our team has assisted LIQUENT InSight clients with hundreds of implementations, upgrades, and optimizations efforts.

Fiesta Welcome ReceptionNetwork with other attendees over a dinner reception hosted by the Westin Riverwalk Hotel. End the evening on the hotel balcony overlooking the riverwalk.

Registration/Welcome Desk

End of Pre-Conference

LUNCH

BREAKFAST

End of Day 1

Product & Solutions RoadmapPaul Ireland, Senior Director, Product Solutions, Kate Courter, Vice President, Client Enablement, & Maria Latulippe, Senior Director, Software Development, PAREXEL Informatics

(The Test Lab is Open - Carranza)

1:00-1:15pmNavarro A

12:00-1:00pmHidalgo

1:15-2:00pmNavarro A

2:15-3:00pmNavarro A

3:15-4:00pmNavarro A

4:00-5:00pmNavarro A

2:00-2:15pm

3:00-3:15pm

Welcome & IntroductionsJulie Shallis Burgess, Manager, Strategic Regulatory Information Management, PAREXEL® Informatics

BREAK

BREAK

PAREXEL Informatics OverviewKen Faulkner, Corporate Vice President, Medical Imaging, PAREXEL Informatics

Business UpdateJeff Huntsman, Vice President, Regulatory Information Management, PAREXEL Informatics

PAREXEL Regulatory Outsourcing Services UpdateRick Riegel, Corporate Vice President, PAREXEL Regulatory Outsourcing Services, PAREXEL Consulting

9:00am-12:00pm

LIQUENT InSight for Registrations™ Mini TrainingA hands-on and interactive session highlighting new features found within Registration Planning and Tracking and Product Detail Management.

LIQUENT InSight for Submission Management™ & LIQUENT InSight Publisher™ version 5.1An interactive session highlighting new product features.

Pre-Conference Workshops9:00am-12:00pm

Navarro A - Ballroom Level

9:00am-12:00pmNavarro B - Ballroom Level

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DAY 2 | Tuesday, April 8th

*Meet in the Lobby at 6:45pm 7:00-10:00pm

4:00pm

On The RanchEscape the hustle and bustle of the city for a bit of Texas and a whole lot of fun! Enjoy an evening at the Rio Cibolo Ranch.

End of Day 2

9:00am-1:45pm

2:00-4:00pm

1:45-4:00pm

2:00-2:30pm

2:30-3:00pm

3:00-3:30pm

1:45-2:00pm

10:30-10:45am

Keynotes & General Session

TRACK 1NAVARRO A

TRACK 2NAVARRO B

The Test Lab is Open

Outsourcing EU & ROW Submissions Using Submission Services

Meredith Sewell, Allergan, Inc.

Global Publishing: National Submission UniquenessVincent Peszek, Pfizer Inc.

Defining and Future Proofing Outsourcing StrategiesKaren Towns, Pfizer Inc.

Registration Management and Product Release Considerations

Nicholas Walzer, Biogen Idec

Partnering for SuccessRich Weber & John Kiser, AbbVie Inc.

Global RIM Approach for Ease of Compliance & Data Quality ImprovementDr. Rene Jung, Bayer Pharma AG

BREAKFAST

BREAK

LUNCH

BREAK

OPAL 3: Story of an Upgrade- Simplification and Alignment

Sandra Herr, GlaxoSmithKline

Scaling up LIQUENT InSight® Registrations Planning & Tracking Module to Ensure Readiness for the Identification ofMedicinal Products (IDMP) Standards Bill Mandarino, UCB, Inc.

IDMP Panel Discussion - Understanding, Planning, Approach, and VisionJulie James, Blue Wave Informatics LLP, John Kiser, AbbVie Inc., & Bill Mandarino, UCB, Inc.

LD Case Study: Helping US Companies Submit JNDA in JapanMichael Epstein, Allergan, Inc.

8:00-9:00amHidalgo

9:00-9:45amNavarro A

9:45-10:30amNavarro A

10:45-11:30amNavarro A

12:45-1:45pmNavarro A

3:30-4:00pmNavarro A

11:30am-12:45pmHidalgo (The Test Lab is Open - Carranza)

Pfizer Case Study: Organizational Transformation Through Regulatory Tracking OptimizationBoris Braylyan, Kara Alfonso, & Jon Grant, Pfizer Inc.

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DAY 3 | Wednesday, April 9th

1:00-4:00pm

9:30-10:30am

9:00-9:30amNavarro A

11:00-11:45amNavarro A

11:45am-12:00pmNavarro A

9:30-10:00am

10:00-10:30am

10:30-11:00am

12:00pm

4:00pm

Closing Forum - The TakeawayJulie Shallis Burgess, Manager, Strategic Regulatory Information Management, PAREXEL® Informatics

Global Change Management for Alcon: Regulatory Impact on LIQUENT InSight® ManagerLynnda McCoy, Alcon, a Novartis Company

Post Conference Workshops

TRACK 1NAVARRO A

TRACK 2NAVARRO B

The Test Lab is Open

ROW Product Registrations Made Easy– Utilizing Electronic Tools

Amy Benson, Grifols Inc.

Harmonizing Generics & Branded BusinessKevin Tompkins, Teva Pharmaceuticals

LIQUENT InSight® in the New Knowledge EconomyMatthew Neal, Amgen Inc.

BREAKFAST

BREAK

LUNCH

End of Full Conference

End of Day 3

RIM at a Medical Device Company: Explaining to Management What is Needed; Working Effectively with IT

Daniel Moelands & Jacque Osmian, Medtronic, Inc.

(The Test Lab is Open - Carranza)

(The Test Lab is Open - Carranza)

8:00-9:00amHidalgo

9:00am-4:00pmCarranza

12:00-1:00pmHidalgo

1:00-4:00pmNavarro A

1:00-4:00pmNavarro B

User Voice “Live”An interactive session with our Product Management Team to discuss current and future features and functionality of the LIQUENT InSight® Platform.

LIQUENT InSight for Publishing™ Certification Training Prep ClassThis half day session will assist in your preparation for the LIQUENT InSight for Publishing Certified Professional Examination. Each student will have the opportunity to practice their publishing skills with hands-on exercises.

Managing Regulatory Agency Questions and CommitmentsDave Miller & Hermineh Aghanian, Amgen Inc.

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CLIENT ENABLEMENT TEAM

This year our Client Enablement team will be in the Test Lab and available for one-on-one appointments. Our team has assisted LIQUENT InSight® clients with hundreds of implementations, upgrades, and optimization efforts. Please stop by or sign up for an appointment if you need any assistance or would like to hear more about our Best Practices.

WHAT’S NEW AT HORIZONS THIS YEAR?

CERTIFICATION EXAM | Thursday, April 10th

12:00-1:00pmLantana Foyer

9:00am-12:00pmLantana

1:00-4:30pmLantana

8:00-9:00amLantana Foyer

4:30pm

LIQUENT InSight for Publishing™ Certification Exam, Part 1The first half of the exam, students will answer questions about using the LIQUENT InSight system for Publishers.

LIQUENT InSight for Publishing Certification Exam, Part 2Certification consists of a practical exam, in which students will create an eCTD using provided source documents and electronic copies of required output.

BREAKFAST

LUNCH

End of Certification Exam

IDMP PANEL DISCUSSION

The intention of this session is to have both panel and audience participation in a discussion of how IDMP fits into your company’s RIM strategy. What have you done to prepare for IDMP execution? What challenges have you faced? What lessons have you learned? These are a few topics that our panelists are going to provide answers for based on thier experience and knowledge of IDMP.

• Do Companies Understand IDMP

- How areas of your business will be affected- Impact on affiliates

• Discussion On Planning For IDMP

- Gap analysis- How significant is IDMP?

• Discussion On Approach

- Big bang vs. incremental changes- Which business areas should be addressed first

• Discussion On Vision

- The benefit of IDMP beyond being a compliance reason