Planning for Success: Early Opportunities to Set the Course for Successful Global Marketing Authorization

Early planning of your marketing authorization strategy is crucial to the development of a comprehensive dossier filing and to avoiding potential delays or refusal to file down the line.

While achieving global marketing authorization approval is one of the end goals of the product development process, many companies don’t start considering their marketing application strategy until well into their Phase III program, losing out on opportunities to save time and help ensure accuracy downstream.

Common challenges and pitfalls that companies face as a result of gaps in planning their marketing authorization strategy early on include:

• Failure to understand global, regional, and local requirements for filing
• Incomplete or suboptimal presentation and analysis of data including safety, benefit-risk, and external data sets
• Missed opportunities to move into new global markets
• Last minute documentation and data chaos

By attending this webinar you will learn how planning can help avoid costly delays and quality issues.

Topics covered in this webinar will include:

• Understanding the landscape for the dossier
• Assessing the history of the compound
• Conducting a gap or SWOT analysis of the dossier (available documentation and data and country specific requirements)
• Developing the project plan for the dossier, the data integration plan, and the statistical analysis plan
• Preparing for Regulatory agency meetings

Speakers

Terry Weber Sosa, Vice President, Biostatistics, Quintiles

Terry Weber Sosa has more than 25 years experience in clinical trials in both the CRO and Pharmaceutical setting. Terry joined Quintiles Biostatistics in 1992 and is currently head of North America Biostatistics Operations covering the US and Canada sites. In this capacity she has oversight responsibility in terms of resourcing, training and career development. In addition, her experience includes overseeing all aspects of running the business including budgeting, sales, financial targets, profitability, customer delivery and satisfaction, long-term strategy and initiatives, etc. She has served as biostatistical lead and consultant on many large, multi-study programs (including global studies) and submission programs. She has broad experience covering all phases of clinical trials (Phase I-Phase IV) with extensive experience in Phase III studies, regulatory submissions (NDAs, BLAs, etc), including electronic submissions, interaction with the FDA and Health Canada and participation in FDA and Health Canada meetings (Pre-NDA, end of Phase II, etc). She has strong knowledge of current regulatory requirements such as ICH guidelines, CDISC and CTDs. Her therapeutic experience includes Women’s Health, Reproductive Female, CNS, Dermatology, Analgesics/Pain, and Blood Substitutes. Terry is an ASA accredited statistician and has also been a member of the ASA Accreditation Committee since its inception in 2010. Terry also sits on the Professional Advisory Council for the Masters of Biostatistics Program at Duke University that was newly formed in Fall 2011.

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Laurie Henricks, Senior Director, Head of North America Regulatory Affairs, Quintiles

Laurie joined Quintiles and its predecessor companies in 1986. She is the head of North America Regulatory Affairs within Global Regulatory Affairs. Her team is responsible for submission planning and development for North America regulatory agencies. Laurie has strong leadership and management skills. Laurie has advanced knowledge of IND, NDA/BLA/MAA, CTD/eCTD, and Clinical Study Report structure, content, and assembly including electronic and paper NDAs, BLAs, MAAs, CTDs, INDs and CSRs. Laurie has extensive experience in submission planning, implementation of dossier style standards; training on electronic submissions, design and implementation of document management and publishing systems; development of submission and publishing processes using document management tools; classroom training; design and implementation of submission standards and publishing technologies; planning and negotiation with local and client project teams; and development and implementation of departmental policies. Prior, Laurie was the head of the Global Publishing team responsible for publishing and compilation of paper and electronic regulatory, clinical, and nonclinical documents and submissions for global regulatory agencies. Laurie is a member of Drug Information Association (DIA), the DIA Special Interest Area Committee (SIAC) for Document Management/eCTD and Regulatory Affairs Professional Society (RAPs). Laurie received ISI Toolbox certification for PDF document preparation and her GCP Certification.

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