Regulatory Information Management

Regulatory Information Management Conference: April 24-25, 2012 Loews Hotel, Philadelphia, PA, USA INSERT PHOTO PROGRAM COMMITTEE Executive Director and Writing Services Director Operations Marr Consultancy Ltd WHO SHOULD ATTEND Professionals involved in: Clinical research & development/clinical supplies eclinical Global project managers Information technology Regulatory affairs/operations Regulatory Information Management Regulatory, medical, and technical writers LEARNING OBJECTIVES At the conclusion of this conference, participants should be able to: Identify key business drivers for establishing a global regulatory information management system Share industry best practices related to standards and processes needed for effective regulatory information management Recognize the important role of regulatory intelligence in a regulatory information management strategy Exhibit Opportunity: Shannon M. Lewis, Exhibits Associate Phone +1.215.442.6149 Fax +1.215.442.6199 Email: shannon.lewis@diahome.org Worldwide Headquarters Drug Information Association, Inc. 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China Regulatory Information Management (RIM) Regulatory departments are continually being asked to do more with less. In addition, regulatory authorities are increasing the scrutiny related to patient safety and compliance with approved application information. As regulatory departments are challenged to develop global regulatory strategies, coupled with the corporate desire to launch in global markets early, the need to understand the regulatory requirements for filing, timelines, what products are approved in which markets is becoming a critical regulatory need for both industry and regulators. Effective regulatory information management processes and tools are needed to ensure the organization remains compliant with its product registrations. This conference will feature a business focused track and a technology focused track. The Business Track will provide the opportunity to interact and share experiences related to processes for obtaining and managing regulatory information and the organizational impact. The Technology Track will focus on standards related to submission of regulatory information, the tools necessary to effectively manage the information, and associated implementation experiences and lessons learned. FEATURED TOPICS Business Track Regulatory intelligence issues and challenges Managing RIM during mergers, acquisitions, and in- or out-licensing Management of correspondence and commitments Upcoming standards and potential impacts (EVMPD, RPS) Challenges with global information management Tools and Technology Track Best Practices for management of regulatory activities using electronic tools Creating a business case for a RIM system Challenges for multi-national organizations with implementation of RIM tools Using RIM tools to achieve compliance Regulatory Intelligence Using tools to aid business decisions Transitioning a business to a global RIM system FEATURING SPEAKERS FROM: Laboratories Bristol Myers Squibb Advyzom CSC Life Sciences Allergan, Inc. Amgen Inc. Eisai, Inc. Bausch & Lomb Evaluserve Biogen Idec FDA Biomedical Research Gens and Associates Institute This program developed by the DIA Special Interest Area Communities (SIAC) GxPi, Inc. Regulatorium Teva Pharmaceuticals ViroPharma

2 Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102. As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer up to 1.2 CEUs for the conference. Participants must attend the entire conference, in order to be able to receive an IACET statement of credit. No partial credit will be awarded. If you would like to receive a statement of credit, you must attend the conference, sign-in at the DIA registration desk each day of the conference, and complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on May 9, 2012. MONDAY, APRIL 23, 2012 4:00-5:30 PM CONFERENCE REGISTRATION DAY 1 TUESDAY, APRIL 24, 2012 7:15-8:15 AM PROGRAM REGISTRATION AND CONTINENTAL BREAKFAST 8:15-8:30 AM WELCOME AND OPENING REMARKS Carlos Fulcher Worldwide Deputy Executive Director DIA CONTINUING EDUCATION 8:30-9:15 AM PLENARY SESSION 1 Keynote Speaker: Issues and Challenges in Managing Regulatory Information David Hovland, PhD Senior Director, Global Allergan, Inc. 9:15-10:00 AM PLENARY SESSION 2 2011 Regulatory Information Management (RIM) Benchmarks and Trends Steve Gens Managing Partner Gens and Associates Inc. Please Note: If you do not sign-in each day, you will not be able to request continuing education credits. The conference is part of DIA s Certificate Program and is awarded the following: Clinical Research Certificate Program: 8 Elective Units For more information go to www.diahome.org/certificateprograms Disclosure Policy It is Drug Information Association policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials. Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda, and CE information are subject to change without notice. Recording of any DIA educational material in any type of media, is prohibited without prior written consent from DIA. To view DIA s Grievance Policy, please visit the CE page on DIA s website at www.diahome.org. 10:00-10:30 AM REFRESHMENT BREAK 10:30-12:00 PM CONCURRENT SESSION 3 SESSION 3A: BUSINESS TRACK Achieving Compliance with Product Registrations Brooke Casselberry Senior Manager, and Medical Writing Effective Management of Global Regulatory Correspondence and Commitments Meredith Brown-Tuttle, RAC Regulatorium FDA Refusal to File Letters: Key Considerations and Metrics Krishnan Viswanadhan, PharmD, MBA Vice President and Partner Advyzom SESSION 3B: TOOLS AND TECHNOLOGY TRACK Evolving Standards: EVMPD and IDMP The Status of IDMP-Standards Finalization and Plans for Implementation Captain Vada Perkins, MSc, BSN, RN Regulatory Program Management Officer Office of the Director CBER, FDA XEVMPD Implementation: Industry s Progress towards the July 2, 2012 Deadline for Submission: Successes and Challenges Industry Perspective on XEVMPD and IDMP John Kiser Senior Director, Global Pharmaceutical

3 12:00-1:30 PM LUNCHEON AND NETWORKING OPPORTUNITY 1:30-3:00 PM CONCURRENT SESSION 4 SESSION 4A: BUSINESS TRACK Balancing the Access and Transparency of Information for Regulated Industry and the Customer Transparency and Access to Information in the United States and Canada Regulatory Policy and Intelligence Global Transparency and Access to Information in the European Region and Rest of World Merete Schmiegelow Director, Regulatory Intelligence SESSION 4B: TOOLS AND TECHNOLOGY TRACK Global Challenges for Regulatory Information Management (RIM) Systems Executive Director, and Writing Services Developing Global Standards & Approaches for Supporting RIM Maintenance Ashley Burt Director, Regulatory Operations Biogen Idec Processes for Effective Data Management and Working with Affiliates Cynthia Piccirillo Director, Global Dossier Management Bristol-Myers Squibb 3:00-3:30 PM AFTERNOON REFRESHMENT BREAK 3:30-5:00 PM CONCURRENT SESSION 5 SESSION 5A: BUSINESS TRACK Managing Regulatory Information Management (RIM) During Mergers and Acquisitions Successful Selection Methodologies for Prioritizing Licensing Opportunities Stephen Galt Engagement Manager Evalueserve Establishing Realistic Expectations for Incorporation of Regulatory Information Executive Director, and Writing Services Ensuring Compliance during the Merger Process Keith Williams Founder and Chief Executive Officer GxPi SESSION 5B: TOOLS AND TECHNOLOGY TRACK Answering Key Regulatory Questions with Advanced Reporting Director, Operations Regulatory Information Management Reporting: The Amgen Approach Matthew J. Neal Director, Global & Safety Amgen Exploit your Regulatory Data with Analytics & Reporting Dan Clark Senior Manager, Strategic Regulatory Innovation Management Level Reporting for Registration and Submission Tracking Randy Chiu Director, Information Systems Allergan, Inc. 5:00-6:00 PM NETWORKING RECEPTION

4 DAY 2 WEDNESDAY, APRIL 25, 2012 7:30-8:30 AM CONFERENCE REGISTRATION AND CONTINENTAL BREAKFAST 8:30-10:00 AM CONCURRENT SESSION 6 SESSION 6A: BUSINESS TRACK The Importance of Regulatory Intelligence in Regulatory Strategy Executive Director, and Writing Services The Understated Piece of the Puzzle Regulatory Information and Regulatory Intelligence Penny Levin Director Regulatory Intelligence & Policy TEVA Global Branded Products Amy Grant Director, Regulatory Strategy and Science ViroPharma Incorporated Regulatory Intelligence Issues and Challenges Kimberly Belsky, MS Director, Policy and Communication, Global Pharmaceuticals Bausch and Lomb SESSION 6B: TOOLS AND TECHNOLOGY TRACK Use of Technology as a Tool to Compliance Director Operations Ultimate Regulatory Information Toolbox: Discovery and Excavation Meredith Brown-Tuttle, RAC Regulatorium Best Practices for Achieving Compliance Amelia Cline IRB Administrator Biomedical Research Institute (BioMed IRB) How can Companies Achieve Operational Efficiencies from Today s Technologies Jennifer Wemstrom Head of Software Solutions Group Strategy CSC 10:00-10:30 AM REFRESHMENT BREAK 10:30 AM-12:00 PM CONCURRENT SESSION 7 SESSION 7A: BUSINESS TRACK Regulatory Intelligence Metric: How to Measure Success Presentation and Interactive Discussion Amy Grant Director, Regulatory Strategy and Science ViroPharma Incorporated Penny Levin Director Regulatory Intelligence & Policy TEVA Global Branded Products SESSION 7B: TOOLS AND TECHNOLOGY TRACK Migrating Regulatory (RIM) Systems: What is the Right Balance Migrating Legacy Information into a New RIM System Susan Metz Director, Product Management Challenges and Learnings from the Process Shakeel Zaki Dar Lean Six Sigma Black Belt 12:00-1:30 PM NETWORKING OPPORTUNITY AND LUNCHEON

5 1:30-3:00 PM CONCURRENT SESSION 8 SESSION 8A: BUSINESS TRACK Managing Information During a Due Diligence Exercise Alan McEmber, MS, RAC Senior Director, Area & Affiliate Strategy Understanding the Business Drivers in Due Diligence Process Jack Chen, PhD Director Scientific Assessment/Technology/Licensing Global Pharmaceutical Licensing and Acquisitions Regulatory Considerations in the Due Diligence Process Set-up and Managing RIM in Due Diligence John Kiser Senior Director, Regulatory Operations RA PPG Global Submission Operations SESSION 8B: TOOLS AND TECHNOLOGY TRACK Evolving Standards: Regulatory Product Submissions Director, Operations Overview of ICH Status as it Relates to RPS Joseph Cipollina Director, Global Dossier Management Bristol-Myers Squibb Current State of RPS Joel Finkle Senior Strategist, Regulatory Informatics Global Professional Services CSC Life Sciences FDA Perspective on Implementing RPS Mark Gray Director, Division of Regulatory Review Support Office of Business Process Support (OBPS) CDER, FDA 3:00-3:30 PM AFTERNOON REFRESHMENT BREAK 3:30-5:00 PM PLENARY SESSION 9 Emerging Markets Executive Director, and Writing Services Managing Regulatory Intelligence in the Diverse and Rapidly Changing Regulatory Environments in Emerging Markets Kim Quaintance Senior Director Global Regulatory Policy and Intelligence Global CFU Eisai, Inc. Panel Discussion: Regulatory Intelligence Management (RIM) Challenges and Issues- Emerging Markets Kim Quaintance Senior Director Global Regulatory Policy and Intelligence Global CFU Eisai, Inc. Erik Hill Director, Global Operations Bausch & Lomb Brooke Casselberry Senior Manager, and Writing Services 5:00 PM WORKSHOP ADJOURNED

REGISTRATION FORM Register online or fax this page to +1.215.442.6199 Regulatory Information Management Event #12005 Workshop: April 24-25, 2012 Loews Hotel, 1200 Market Street, Philadelphia, PA 19017, USA Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks, luncheons, and reception (if applicable), and will be accepted by mail, fax, or online. Member Early-bird Opportunity On or before After Available on nondiscount member fee only APR. 4, 2012 APR. 4, 2012 Member Fee US $1340 US $1490 Join DIA now to qualify for the early-bird member fee! www.diahome.org/membership MEMBERSHIP US $140 To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members. Nonmember Fee US $1630 A one-year membership to DIA is available to those paying a nonmember registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. I want to be a DIA member I do NOT want to be a DIA member Discount Fees MEMBER NONMEMBER Government (Full-time) US $595 US $735 Charitable Nonprofit/Academia (Full-time) US $745 US $885 *If paying a nonmember fee, please check one box above, indicating whether you want membership. TO RECEIVE A TABLETOP EXHIBIT APPLICATION, PLEASE CHECK GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA. Please indicate that this form is part of a group registration by checking this box and list below the names of the other three registrants from your company. 1. 2. TRAVEL AND HOTEL The most convenient airport is the Philadelphia International Airport and attendees should make airline reservations as early as possible. The Loews Hotel is holding a block of rooms at the reduced rate below until April 2, 2012, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled. Single $219 Double $219 Attendees must make their own hotel reservations. Contact the Loews Hotel by telephone at +1.215.627.1200 and mention the DIA event. The hotel is located at 1200 Market Street, Philadelphia, PA 19017, USA. CANCELLATION POLICY: On or before April 17, 2012 Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 Government or Academia or Nonprofit (Member or Nonmember) = $100 Tutorial (if applicable) = $50 Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be respons ible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applic able. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants. Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs. TABLETOP EXHIBIT INFORMATION Attendees may visit the tabletop exhibits during the event and receptions. Contact Shannon Lewis, Exhibits Associate, Phone +1.215.442.6149 Fax +1.215.442.6199, email Shannon.Lewis@diahome.org EVENT INFORMATION For registration questions, please contact Marilyn Ginsberg by phone at +1.215.442.6135 or by email at Marilyn.Ginsberg@diahome.org. For agenda details, please contact Program Manager Victoria Graves by phone at +1.215.919.9863 or by email at Victoria.Graves@diahome.org Please check the applicable category: Academia Government Industry CSO Student (Call for registration information) 3. Last Name Payment options: Register online at www.diahome.org or check payment method. CREDIT CARD number may be faxed to: +1.215.442.6199. You may prefer to pay by check or bank transfer since non-u.s. credit card payment will be subject to the currency conversion rate at the time of the charge. Visa MC AMEX Exp Date Card # Name (printed) First Name M.I. Degrees Dr. Mr. Ms. Job Title Signature CHECK drawn on a US bank payable to and mailed along with this form to: Drug Information Association Inc, P.O. Box 95000-1240, Philadelphia, PA 19195-1240, USA. Please include a copy of this registration form to facilitate identification of attendee. Company Address (As required for postal delivery to your location) Mail Stop BANK TRANSFER When DIA completes your registration, an email will be sent to the address on the registration form with instructions on how to complete the Bank Transfer. Payment should be made in US dollars. Your name and com pany, as well as the Event I.D. # must be included on the transfer document to ensure payment to your account. City State Zip/Postal Country email Required for confirmation Phone Number Fax Number Required for confirmation