17-20 September 2016, San Jose
  • Reviewing your regulatory business plan will put you on the path to advance your core objectives. Learn how to become a key strategic partner, execute efficiently and effectively, plus new tips to keep you on time and under budget. Get prepared to jump on the leadership track as our sessions focus on career development, communication, regulatory intelligence, strategy and decision making.

Regulatory Business

  • Monday, 19 September

    10:00 11:15 am

    Regulatory Influence Through Effective Communication and Negotiation

    How would you rate yourself as a negotiator? As a regulatory professional, skillful negotiation is a must both internally and externally if you want to gain success. After our session you’ll be armored with the tools to be a fearless negotiator. Come sharpen your skills and learn how to develop strategy, win approvals, and conduct successful audits and inspections.

    Critical Thinking Skills

    Critical thinking is the art of using reason to analyze ideas and dig deeper to get to the best results. It combines intellectual curiosity and the ability to take an honest look at yourself, sometimes even in the face of uncomfortable facts. If you want to develop a successful career in regulatory, this session is a must. Senior executives will serve up seven core critical thinking skills that will change how your approach your job on a daily basis.

    11:30 am12:30 pm

    Regulatory Audits for Virtual and M&A Companies: Avoiding Common Mistakes

    Preparing for a regulatory inspection can be stressful. This is especially true for a company that has gone through a merger and acquisition or is a virtual company. A company needs to ensure its quality systems are robust and implemented effectively. During this interactive session, you’ll learn firsthand how to prepare successfully for regulatory audits and receive clearance to commercialize your products globally.

    1:303:00 pm

    Handling Regulatory Challenges: How to Respond With Grace Under Pressure

    A sound strategy on how to respond to regulatory and business challenges can make all the difference in the workplace. Following this session’s success at last year’s Convergence, a panel of regulatory thought leaders will offer hands-on solutions to new challenging scenarios. During this facilitated interactive session, you will be fully engaged and will walk away with creative ways to handle every day regulatory issues.

    Tuesday, 20 September

    8:30–10:00 am

    Dangerous Documents: Avoiding Land Mines in Your FDA Records and Emails

    In our litigious society, seemingly innocuous phrases in an email can be used to undermine your credibility, cost your organization money, and have a negative effect on its reputation. Once you've hit "send," that document lasts forever. Don't let your documents embarrass you. Join us for this high-energy, interactive session where you will learn what you should or should not write in your documents.

    10:30 am–12:00 pm

    Submission Preparation: Beyond the Guidance

    Due to FDA’s size and scope, and despite honest interpretations of the regulations and guidance, sponsors can find it challenging to prepare submissions and other sponsor communications that pass FDA’s screening process and meet the needs of FDA. What happens once a submission is in the hands of FDA staff? Mystery solved. Come to this session prepared to ask questions and obtain insight into the regulatory processes and preferences of CBER, CDER, CDRH staff from FDA representatives, as well as from experienced regulatory professionals.  Learn best practices that can help you prepare successful submissions and sponsor communications that pass screening, are formatted to meet the needs of FDA staff, and get you the answers and results you are looking for. Learn more about FDA’s internal management of applications, sponsor communications and nuances across centers.  

    1:00–2:30 pm

    Real World Evidence: Registry, Observational and Clinical Studies

    In order to develop a thorough story of safety, effectiveness and quality for your product’s performance, gathering real world evidence is essential. How do you do that? Through a registry, observational or clinical study. This session will examine the differences between each one, and provide the why, when and how to implement non-interventional research, which is key in reducing cost and advancing medicines to market.

    3:30–4:45 pm

    Master Class on Regulatory Intelligence Strategic Thinking

    Join us for an interactive session on establishing precedent in regulatory strategy; the role of regulatory intelligence in the development process. Here’s a chance for you to be part of a regulatory team tasked with solving several issues related to product development. The panelists will examine scenarios and case studies and walk through the process of gathering precedent, analyzing the information and providing actionable regulatory intelligence.