Regulatory Writing Meeting (Q1 Productions)

5TH ANNUAL

REGULATORY WRITING FOR PRODUCT APPROVALS APRIL 27-28, 2016 | PHILADELPHIA, PA

WYNDHAM PHILADELPHIA HISTORIC DISTRICT Authoring Compliant and Comprehensive Regulatory Documents for US and Global Submissions with a Thorough Understanding of Submission Review Strategies, Risk Management Plan Requirements through to Outsourcing Considerations

DISTINGUISHED PRESENTERS INCLUDE: Lynne Munno Senior Manager, Medical Writing PHARMACYCLICS, AN ABBVIE COMPANY Wendy Herman Associate Director, Manager, & Oncology DSUR Coordinator Medical Writing JOHNSON & JOHNSON Carrie Mazzrillo Submissions Manager of Global Regulatory Operations EISAI, INC. René Alvarez Associate Director, Medical Writing FIBROGEN Anna Loiodice Scientific Writer REGENERON PHARMACEUTICALS, INC. Amy Compton Senior Manager, Global Regulatory Writer AMGEN Denise Mayes-Gascard, PhD Manager, Transverse Projects, Clinical Documentation Department SANOFI

Lisa Thomson, PhD Senior Manager, Medical Writing SEATTLE GENETICS Leslie Lescale-Matys Medical Writing Group Lead SHIRE Marc Stern Director of Regulatory Processes, Operations and Publishing EAGLE PHARMACEUTICALS Cathy Cummins Global Head Submissions & Documentation NOVARTIS

Becky Nuttall Medical Writing Lead EMD SERONO Paula Wun Senior Director, Medical Writing VERISTAT Rebecca Stawartz Principal Medical Writer ABBVIE

Laura Sheppard, MBA, MA Director, Medical Writing MALLINCKRODT PHARMACEUTICALS

Juli Miller-Robinson Associate Director, Medical & Scientific Writing JAZZ PHARMACEUTICALS

Patrick Cullinan, PhD Director, Global Clinical Trial Transparency TAKEDA

Deborah Smith Manager Medical Writer and RMP Coordinator Oncology JOHNSON & JOHNSON

Rosemarie Pincus Senior Protocol Writer JOHNSON & JOHNSON

CONFERENCE SPONSORS: BRONZE SPONSOR:

Gretchen Griffin, MS Director, Regulatory Writing Strategic Solutions and Operations ABBVIE

DOCUMENTATION SPONSOR:

Madhavi Gidh-Jain Senior Director, Global Regulatory Writing Head OPHTHOTECH

RAPS CERTIFICATION This conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon completion

www.q1productions.com

REGULATORY WRITING FOR PRODUCT APPROVALS DAY ONE | WEDNESDAY, APRIL 27 7:45 REGISTRATION & WELCOME COFFEE

JOINT PRESENTATIONS: REGULATORY OPERATIONS & WRITING EXECUTIVES JOIN FORCES TO STREAMLINE PROCESSES & COLLABORATION TO ENSURE REGULATORY APPROVALS

8:25 CHAIRPERSON’S OPENING REMARKS Paula Wun Senior Director, Medical Writing VERISTAT 8:30 KICK-OFF MEETINGS: CREATING DEADLINE GOALS AND KEY STAKEHOLDER RESPONSIBILITIES • Retrospective project analysis to reduce delays • Balancing writing team and publishing team needs • Prioritizing projects when managing multiple submission projects • Creating stakeholder responsibilities to decrease risk of redundancy LEARNING OBJECTIVES: • Initiating projects with clear and agreed goals • Key priorities for pre-submission planning • Awareness of planning meetings impact on budget Juli Miller-Robinson Associate Director, Medical & Scientific Writing JAZZ PHARMACEUTICALS 9:20 REQUIREMENTS FOR PEDIATRIC DEVELOPMENT • FDA Requirements

- Pediatric Research Equity Act (PREA) - pediatric assessment

- Pediatric Plan and Submissions •EMA Requirements

-Paediatric Investigation Plan (PIP) • Differences in pediatric development requirements: US vs. EU Madhavi Gidh-Jain Senior Director, Global Regulatory Writing Head OPHTHOTECH 10:10 COFFEE AND NETWORKING BREAK 10:40 AUTHORING STRATEGIES FOR SAFETY DOCUMENTS • Reducing redundancy within safety documents • Key content and data requirements - RMP - DSUR - PSUR • Inclusion of post-market safety data Wendy Herman Associate Director, Manager, and Oncology DSUR Coordinator Medical Writing JOHNSON & JOHNSON

3:10 CO-PRESENTATION: REGULATORY WRITING & SUBMISSION PUBLISHING PERSPECTIVES ON EFFECTIVE HYPERLINKING • Determining the most effective amount of hyperlinking - Reduce the risk of over-hyperlinking - Eliminate incorrect or redundant links • Perspectives on criticality of links within dossier sections • Downstream perspectives on effective hyperlinking LEARNING OBJECTIVES • Ensuring hyperlinks support the submission • Provide ease of access to data for reviewer • Analysis of collaborative efforts on hyperlinking Carrie Mazzrillo, Submissions Manager of Global Regulatory Operations EISAI, INC. Anna Loiodice, Scientific Writer REGENERON PHARMACEUTICALS, INC. 4:00 PANEL: ARTICULATING THE IMPORTANCE OF TEMPLATE USE TO PROMOTE DOCUMENT CONSISTENCY • Development of templates that ease writing & submissions • Ensure writers utilize templates provided throughout authoring • Template requirements from each perspective - Importance of correct placement of text - Clear guidance on content formatting • Updates to templates based on regulators’ requirements LEARNING OBJECTIVES • Creation of mutually beneficial templates • Impact of template on operations for writers & operations • Level of regulatory change triggering template change MODERATOR: Marc Stern, EAGLE PHARMACEUTICALS Cathy Cummins, NOVARTIS Amy Compton, AMGEN Anna Loiodice, REGENERON PHARMACEUTICALS, INC. Denise Mayes-Gascard, PhD, SANOFI 4:50 DAY ONE CONFERENCE CONCLUSION

11:30 RISK MANAGEMENT PLANS: DELIVERING A BALANCE BETWEEN PRODUCT BENEFIT, SAFETY AND RISK • Demonstrate a balance between risk & benefit • Current guidelines for risk data inclusion • Architecture of a comprehensive risk management plan • Common feedback from regulators about risk plans Deborah Smith Manager Medical Writer and RMP Coordinator Oncology JOHNSON & JOHNSON 12:20 LUNCHEON FOR ALL ATTENDEES, SPEAKER AND SPONSORS 1:50 EU POLICY 0070: CLINICAL TRIAL DATA TRANSPARENCY AND REDACTIONS • Regulatory requirements for EU Policy 0070 and EMA Policy 43 • Clarifying CCI vs. non-CCI information - Confidential corporate information - Patient privacy data • Redaction responsibilities for regulatory writing teams • Decision parameters for outsourcing redaction practices LEARNING OBJECTIVES: • Reducing overall redaction rejections • Streamlining redaction timelines • Restructured transparency requirements in Europe Patrick Cullinan, PhD Director, Global Clinical Trial Transparency TAKEDA

HOTEL LOCATION WYNHDAM PHILADELPHIA 400 Arch St, Philadelphia, PA 19106

2:40 COFFEE AND NETWORKING BREAK

500 N. DEARBORN STREET, SUITE 500

CHICAGO, IL 60654

(P) 312.822.8100

(F) 312.602.3834

www.q1productions.com

REGULATORY WRITING FOR PRODUCT APPROVALS DAY TWO | THURSDAY, APRIL 28 8:00 REGISTRATION & WELCOME COFFEE 8:25 OPENING REMARKS 8:30 TIME MANAGEMENT FOR SPEARHEADING MULTIPLE PRODUCT SUBMISSIONS • Synchronizing submissions to achieve a balance • Needs analysis to prioritize multiple submission deadlines • Development of a hierarchy within multiple submissions LEARNING OBJECTIVES With a strategic approach to planning for the authorship of multiple simultaneous product submission, writers will be better equipped to coordinate a multitude of deadlines, strict version control and quality creation of numerous support documents.

Rebecca Stawartz, Principal Medical Writer, ABBVIE 9:20 IMPACTFUL PROTOCOL WRITING TO ENSURE QUALITY CLINICAL DATA • Development of an accurate and concise protocol • Ensure all data required is obtained through the study • Data collection and data management parameters • Implications of protocol writing on CSR development for submissions - SAP review - CSR shell creation - Reviews of draft tables and listing • Writing for standard protocols vs. adaptive design protocols LEARNING OBJECTIVES Through a strategic look at the intricacies of protocol writing and the impact of study protocols on the overall success of the clinical study, regulatory writers will gain insight into the importance of comprehensive protocol writing to ensure accurate clinical data is gathered for product submissions.

Rosemarie Pincus, Senior Protocol Writer, JOHNSON & JOHNSON 10:10 COFFEE AND NETWORKING BREAK

1:30 VERIFYING DOSSIER QUALITY THROUGH SUBMISSION AND CONENT REVIEW MEETINGS • Establishing review expectations • Parameters for grammar and content clarity checks • Key personnel involved in quality checks - Regulatory writing team - Submission publishers - Regulatory affairs • Conducting quality checks against source data • Timelines set up for review meetings Laura Sheppard, MBA, MA, Manager, Medical Writing MALLINCKRODT PHARMACEUTICALS 2:20 PRACTICAL GUIDANCE AND BEST PRACTICES FOR DEVELOPING AND MAINTAINING INVESTIGATOR BROCHURES • Determining when a new IB or update is needed • Planning the IB, including the inclusion of appropriate content to support clinical participation • Organizing and facilitating strategic meetings • Writing and managing the IB content • Facilitating strategic review of the IB Lynne Munno, Senior Manager, Medical Writing PHARMACYCLICS, AN ABBVIE COMPANY 3:10 CASE STUDY: INTEGRATION OF CLOUD BASED DOCUMENT MANAGEMENT IN REGULATORY WRITING • Validation of cloud based systems for regulatory writing • Collaborative capabilities of cloud document systems - Editorial sharing - Version control • Document security and confidentiality concerns René Alvarez, Associate Director, Medical Writing, FIBROGEN 4:00 CLOSING REMARKS AND CONFERENCE CONCLUSION

10:40 PANEL DISCUSSION: EDITING CONSIDERATIONS FOR SUBMISSION DOCUMENTS • Avoiding edits to verbatim data from source materials • Designating a final authority decision maker • Editorial comment specificity - Clear text changes - Data edits vs. writing style comments • Develop editorial timelines for success LEARNING OBJECTIVES • Reducing reviewer fatigue • Editorial checklist development • Integration of edits into final submission MODERATOR: Paula Wun, VERISTAT Laura Sheppard, MBA, MA, MALLINCKRODT PHARMACEUTICALS Becky Nuttall, EMD SERONO René Alvarez, FIBROGEN Gretchen Griffin, MS, ABBVIE Leslie Lescale-Matys, SHIRE 11:30 SUCCESSFUL AUTHORING PARTNERSHIPS WITH VENDORS AND CONTRACT WRITERS • Blended writing teams of internal and contract writers - Cohesive writing voice throughout documents • Establish corporate tone • Develop clear guidelines - Dividing authorship responsibilities • Risk based approaches • Building collaborative writing environment with remote authors - Leverage of technology to ensure collaboration - Relationship building with contract writers • Integrating documents from outsourced writers Lisa Thomson, Senior Medical Writer, SEATTLE GENETICS 12:20 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS

500 N. DEARBORN STREET, SUITE 500

CHICAGO, IL 60654

ABOUT THE ORGANIZERS Q1 Productions designs and develops webinars, training courses, conference programs and forums aimed at specifically targeted audiences in order to provide strategic and timely information. Through a rigid production process focused on end-user research and design, our team is able to understand the immediate business concerns of today’s leading executives.

Whether focusing on new or pending legislative issues, enhanced business processes or technologies that will drive efficiency and customer service, our programs provide solutions to the urgent needs of our attendees.

(P) 312.822.8100

(F) 312.602.3834

www.q1productions.com

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