An exciting event appealing to advanced and beginner ... · Michael John Mihm, PhD, Associate Medical Writing Program Director, ASTELLAS 2:30 Medical Writing Fellowship Program to

TO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITE

Forum MedicAl WritingClinical Regulatory

Ensure structured content, efficient review processes and streamline submissions

while remaining compliant with the changing regulatory guidelines

SpeAkerS:Aaron Bernstein PhD, Director, Clinical Medical WritingACTAVIS

Impact of Clinical Trial Registration and

Results Disclosure on Medical Writing

ICH M4 Guidelines and the Increasing

Need for US Integrated Summaries

Medical Writing Challenges in Creating a

Global New Drug Application

Examine the Changing Trends in

Resourcing

Standardization of Protocol Documents

and Component Authoring

New Implementation of Metrics to Measure

Operational Effectiveness

Structured Content Management to

Increase Quality and Decrease Workload

Emerging Importance of Patient

Reported Outcomes

event highlightS

TO REGISTER CALL: 201 871 0474

July 14-15, 2014 | Loews philadelphia hotel | philadelphia, pA


Joan Affleck Associate Vice President, Global Head of Clinical Documentation SANOFI

• Kim Norris, Director, Medical Writing,SYNTA PHARMACEUTICALS

• Jane Stephenson, PhD, MBA, Director of Medical Writing,BOEHRINGER INGELHEIM

• Wendi Lau, Senior Director, Medical Writing, ASTELLAS

• Douglas Smith, Director, Medical Writing Group Leader,ACTELION PHARMACEUTICALS

• Sophia Kourliouros, Senior Manager, Regulatory Submissions, EISAI

• Dylan Harris, Associate Director, Medical Writing,GENZYME, A SANOFI COMPANY

Cathy Cummins Global Head, Submissions and Documentation NOVARTIS

An exciting event appealing to advanced and beginner writers, providing insight to meet the challenges of changing health authority requirements.

-Cathy Cummins, Global Head, Submissions and Documentation, NOVARTIS“ ”

Neal Azrolan, MBA, PhD, Safety Evaluation and Reporting PFIZER

TO REGISTER CALL: 201 871 0474 TO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITE

Dear Colleague,

The task facing Regulatory Medical Writers is becoming increasingly more complex. The challenge of interpreting and translating immense amounts of complex clinical data into clear and comprehensive regulatory documents has become overwhelming. In addition, regulatory guidelines are constantly evolving. Navigating the continual changes in ICH guidelines, transparency, clinical trial disclosure, protocol deviation and global submissions is critical to the success of Regulatory Medical Writers. It is critical that they possess a thorough understanding of key documents and regulatory guidelines to ensure efficient product approval.

ExL Pharma’s Clinical Regulatory Medical Writing Forum provides a platform for Medical Writing and Regulatory Submission professionals to learn, benchmark and understand key criteria necessary to effectively compose regulatory documents. This forum will allow delegates to hear industry experts share best practices through case studies, panel discussions and spotlight sessions. Additionally, this two day program will deliver valuable information on a wide variety of important topics including protocol development, Medical Writing outsourcing, global new drug applications, data and information sharing, safety update reports, integrated summaries and many more!

Join us in Philadelphia this July as we tackle the critical issues facing Regulatory Medical Writers!

Sincerely,

Nicole deVoeNicole deVoe Conference Production DirectorExL Pharma

Who Should Attend

This conference is of interest to

professional from Pharmaceutical,

Biotechnology and Medical Device

companies, involved in Clinical

Regulatory Medical Writing with

the following job functions:

• Clinical Medical Writing

• Scientific Writing

• Submissions Management

• Technical Writing

• Regulatory Affairs/Operations

• Clinical Affairs/Operations

• Electronic Submissions

• Medical Affairs

• Publication Writing

• Reporting

• Clinical Documentation

This conference is also of interest to:

• Document Application Suppliers

• Information Management

Consultants

• Clinical Research Organizations

• Research Informatics

• Medical Writing Services

• Bibliographic Software

• Component Authoring Software

• Publication Service Providers


SponSorShip And exhibiting opportunitieS Do 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 Pharma will work closely with you to customize a package that will suit all of your needs.

Scott Grossman Production Team Lead ExL Pharma

MEDIA PARTNERS:

TO REGISTER CALL: 201 871 0474 TO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITE

8:00 Registration and Continental Breakfast

8:45 Chairperson’s Welcome and Opening RemarksCathy Cummins, Global Head, Submissions and Documentation, NOVARTIS

9:00 Management Strategies and Tools for Expediting the Development of Regulatory Submission Protocols • Utilize tools to assist the protocol team to ensure that every

data point needed to be addressed in the clinical study report is captured in the protocol

• Strategies to quickly receive consensus from opposing parties• Ensure clean, consistent and compliant protocolsKim Norris, Director, Medical Writing, SYNTA PHARMACEUTICALS

9:45 Best Practices for Efficient and Effective Composition of Investigator Brochures• Management strategies for effective investigator brochure

composition• Ensure production of investigator brochures is pursuant to

FDA guidelines• Best practices for handling amendmentsJane Stephenson, PhD, MBA, Director of Medical Writing, BOEHRINGER INGELHEIM

10:15 Networking and Refreshment Break

10:45 Medical Writing Challenges in Creating a Global New Drug Application • Regulatory clinical perspective – Focus is on Summary of

Clinical Efficacy (SCE)/ Integrated Summary of Effectiveness (ISE), Summary of Clinical Safety (SCS)/ Integrated Summary of Safety (ISS) and Clinical Overview (CO)

• Review main guidelines associated with regulatorysubmissions

• Aging guidelines: US FDA Clin-Stat guideline (1988) andCommon Technical Document (2003)

• Changing regulatory environment: High profile safety issueshave resulted in more stringent requirements

• Recent guidelines/ guidance documents need to be consideredin the preparation of the dossier

• Possibility of producing a single document for different regions• Can the CTD SCE and SCS fulfill the requirements of the US

ISE and ISS• What region-specific documents may be requested

(e.g., in East Asia and Latin America)Douglas Smith, Director, Medical Writing Group Leader, ACTELION PHARMACEUTICALS

11:30 Use Module 5 Integrated Summaries of Efficacy and Safety to Craft Module 2 Summaries Efficacy and Safety • Understand FDA requirements for Integrated Summaries of

Efficacy and Safety for Module 5 of drug applications • Learn to prepare Module 2 and 5 documents simultaneously,

so that only the Module 5 documents will need to be prepared and rigorously reviewed

Catherine Farrell, PhD, Senior Associate Director, Medical Writing, BOEHRINGER INGELHEIM

12:15 Luncheon

1:15 Challenges, Opportunities and Approaches in a Cross-Functional Review Process• Understand cross-functional reviews and the role(s) of the

Medical Writer • Explore the challenges and opportunities in facilitation and

adjudication of cross-functional reviews• Compliance and its impact on a Medical Writer• Learn tools and approaches for the Medical Writer and their

teamNeal Azrolan, MBA, PhD, Safety Evaluation and Reporting, PFIZER

2:00 Develop Effective Partnerships when Outsourcing Medical Writing Responsibilities • Discuss various models for outsourcing Clinical Regulatory

Medical Writing • Ensure quality standards when outsourcing Medical Writing• Explore the pros and cons of different vehicles for outsourcing

Medical WritingWendi Lau, Senior Director, Medical Writing, ASTELLAS


3:15 Analyze the Changing Trends in Resourcing • Assessments of the complexity and available workload to

outsource • Ensure document standardization between internal and

outsourced parties • Define clear efficiency and quality KPIsDylan Harris, Associate Director, Medical Writing, GENZYME, A SANOFI COMPANY

4:00 Effectively Prepare Integrated Summaries for the Common Technical Document • Understand ICH M4E Guideline and the need for US

Integrated Summaries and ICH mandated Clinical Summaries when submitting NDAs and sNDAs to the US FDA

• Explore options for efficiently preparing Integrated Summariesof Efficacy, Clinical Summaries of Efficacy, Integrated Summaries of Safety and Clinical Summaries of Safety

• Discuss processes around the preparation of these complexdocuments and the factors used in determining when all document types are required. Also when a single efficacy and single safety summary is acceptable

Dr. Aaron Bernstein, Director, Clinical Medical Writing, ACTAVIS

Sophia Kourliouros, Senior Manager, Regulatory Submissions, EISAI

Cathy Cummins, Global Head, Submissions and Documentation, NOVARTIS

5:00 Conference Chairman’s Closing Remarks Cathy Cummins, Global Head, Submissions and Documentation, NOVARTIS

5:15 Day One Concludes


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TO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITE TO REGISTER CALL: 201 871 0474 TO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITE

8:00 Continental Breakfast

9:00 Chairperson’s Recap of Day OneCathy Cummins, Global Head, Submissions and Documentation, NOVARTIS

9:15 Data, Information, Knowledge and Wisdom: Role of the Medical Writer in Clinical Data and Information Sharing • Explore the current requirements and trends in clinical trial

disclosures and how that impacts Medical Writing• Best practices for data and information interpretation:

the importance of context and perspective• Understand the challenges and opportunities for the Medical

WriterNeal Azrolan, MBA, PhD, Safety Evaluation and Reporting, PFIZER

10:00 Implement Component Authoring to Improve Medical Writing Efficiencies • Review of component authoring• Understand the benefits of document reuse• Strategies to change the document writing mindset to

component authoringCathy Cummins, Global Head, Submissions and Documentation, NOVARTIS


11:15 The Emerging Importance of Patient Reported Outcomes• Discuss the importance of electronic capture of PRO endpoint

data in clinical trials• Explain the design of PRO assessment tools and appropriate

selection and use of such tools• Advantages and disadvantages of working collaboratively

within a pre-competitive consortium to develop and qualifyPRO instruments for use in clinical trials where PROendpoints are used to support product labeling claims

Asha Jayakumar, Scientific Writer, BIOGEN IDEC

12:00 Structured Content Management: A New Approach for Medical Writing in the Pharmaceutical Industry • Introduce structured content management to our industry• Understand benefits of structured content management in

Medical Writing• Learn successful implementation strategiesJoan Affleck, Associate Vice President, Global Head of Clinical Documentation, SANOFI

12:45 Luncheon

1:45 Metrics and Reporting Methodologies to Measure Operational Effectiveness • Measure or quantify the effectiveness of regulatory operations

management• Construct dashboard measurements to employ over time• Analyze KPIs to best allocate resources and manpowerMichael John Mihm, PhD, Associate Medical Writing Program Director, ASTELLAS

2:30 Medical Writing Fellowship Program to Produce Successful Medical Writers • Characteristics and background to look for when hiring a

Medical Writer• Establish programs for successful development of Medical

Writers• Examine aspects of Sanofi Medical Writing Fellowship

programDebra Stamper, Principal Medical Writer, SANOFI

3:15 Conference Chairperson’s Closing Remarks Cathy Cummins, Global Head, Submissions and Documentation, NOVARTIS

3:30 Conference Adjourns

dAy tWo tueSdAy, July 15, 2014

Excellent topics. This looks like a very interesting meeting! - Sr. Director, Global Medical Writing, ALCON LABS

This meeting sounds wonderful! - Sr. Medical Writing Scientist, JOHNSON & JOHNSON

Topics are sure to produce healthy discussions. - Principal Medical Writer, PFIZER

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What Your Colleagues are Saying About This Meeting

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TO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITETO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITE

Registration Fees Early Bird Pricing Register by 5/30/2014 ........................... $1895Standard Pricing Register after 5/30/2014 .......................... $2095Onsite Pricing ................................................................. $2195

Questions? Comments?Do you have any questions, comments on the program, or have specific topics you would like addressed? Would you like to get involved as a speaker, moderator or discussion leader? Please email.

Group Discount ProgramsSave 25% per person when registering fourFor every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at a time).Save 15% per person when registering threeCan only send three? You can still save 15% on each registration.

Payment Make checks payable to ExL Events, Inc. and write code C523 on your check. You many also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer, and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. Please note, there will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.

Cancellation PolicyIf you need to cancel your registration for an upcoming ExL conference, please not the following polices derived from the Start Date of the event: Four weeks or more: A full refund (minus $295 processing fee), or a voucher to another ExL event valid for 18 months from the voucher issue date.Four weeks or less: A voucher to another ExL event valid for 18 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher will be $395 less.To receive a refund or voucher, please fax your request ExL Pharma reserves the right to cancel any conference it deems necessary and will not be responsible for airfare, hotel, or any other costs incurred by registrants. ExL Pharma’s liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speaker or venue.

Terms and ConditionsBy registering for an ExL Events, Inc. (“ExL Pharma”) event, you agree to the following set of terms and conditions listed below:Registration Fee: The fee includes the conference, all program materials and designated continental breakfasts, lunches and refreshments.The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL events, Inc.The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL Events, Inc.’s (“ExL’s”) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposed of copywriting, not redistribution to other outlets without the express written permission of ExL’s designated speaking par-ties. Neither ExL, nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY OF THE CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of or endorse the views or opinions give by any third party content provider. ExL presentations may point to the other Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

VenueLoews Philadelphia Hotel 1200 Market Street, Philadelphia, PA 19107Direct Line: 215-627-1200Reservations: 888-575-6397To make reservations please call 888-575-6397 and request the negotiated rate for ExL’s July Meeting. The group rate is available until June, 23, 2014. Please book your room early, as rooms available at this rate are limited.

TO REGISTER CALL: 201 871 0474

”

TO REGISTER CALL: 866-207-6528 VISIT: www.ExLphARmA.COm/mEdwRITE TO REGISTER CALL: 201 871 0474


July 14-15, 2014 | Loews philadelphia hotel | philadelphia, pA

Aaron Bernstein PhD, Director Clinical Medical WritingACTAVIS

Cathy Cummins Global Head, Submissions and Documentation, NOVARTIS

Neal Azrolan, MBA, PhD, Safety Evaluation and Reporting, PFIZER

Joan Affleck Associate Vice President, Global Head of Clinical Documentation, SANOFI

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