REGULATORY BUSINESS

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.

MONDAY, 11 SEPTEMBER
10:30 am–12:00 pm

Regulatory Obligations and How to Deal With Unethical Requests

Have you ever found yourself in a situation where you knew it was wrong but didn’t know how to handle it? As a regulatory professional, we have a code of conduct that we should follow, but sometimes it’s not that easy. Have you been asked to sign a document before reading it? What do you do when someone back dates a signature in front of you? Or what if you know that data in a report has been falsified? After this session, you will have new tools for dealing with these situations and others. Come test your skills in this interactive session. There will be time to ask questions, acquire new tools and share your stories.

 

Stephen Amato, PhD, MBA, RAC, program director-associate professor graduate regulatory affairs/market access program portfolio, Northeastern University
Tamas Borsai, division manager, MHS customer service and quality, TUV SUD America
Raina Dauria, MS, RAC, senior director of regulatory affairs, Ethicon Biosurgery
Jan Flegeau, regulatory affairs manager, Sterilmed, a Johnson & Johnson Company



1:15–2:45 pm

Mergers and Acquisitions

Mergers and acquisitions (M&A) are perhaps the most common means for growing market access and product portfolios in the medical device industry and beyond. In addition to due diligence of the target acquisition's quality systems and regulatory standing, an integration plan that merges two cultures and practices is also in order. During this session, we will walk you through real-life examples of recent M&A activities in our industry. You will learn how to look for potential issues in the quality system and where the hidden items like to hide. Find out what to do when you find a potential challenge, including risk-based tactics for remediation. Plus, we’ll review what success looks like once challenges are adequately addressed.


Roberta Goode, MS, president, CEO, Goode Compliance International


4:00–5:30 pm

The Secrets of Successful Meetings With Health Authorities—What You Don’t Know May Hurt You

Imagine if you had a reputation for preparing meetings with health authorities that led to great outcomes. Well-run meetings are effective ways to make decisions, solve problems, and build long-term positive relationships with regulators. Mastering the art and science of effective regulatory interactions can make a difference in your job. During this facilitated interactive session, a panel of thought leaders will offer hands-on advice to challenging scenarios. You will be fully engaged and will walk away with best practices on how to prepare and run successful regulatory meetings.


Don Boyer, RAC, FRAPS, president, BOYER@RegulatorySolns
Daniela Drago, PhD, director, clinical and translational research, The George Washington University  
Michael Morton, FRAPS, vice president, corporate regulatory affairs, Medtronic (retired)
Fortunato Senatore, MD, PhD, FACC, medical officer, OND, CDER, FDA


TUESDAY, 12 SEPTEMBER
8:30­­–10:00 am

Key Takeaways From the Master Class in Regulatory Intelligence: RI as a Strategic Imperative

Join us for a hands on session on the role of regulatory intelligence and locating and using precedent in an ever-evolving global environment of therapeutic product regulatory strategy. Here’s a chance for you to be part of a regulatory team tasked with addressing several real-world examples of strategic issues encountered during development. Case studies of properly executed RI demonstrate how to provide actionable intelligence leading to innovative solutions solving common problems encountered in product development. The panelists will provide key takeaways from the Master Class in Regulatory Intelligence Sunday Workshop and examine scenarios and case studies and walk through the process of gathering precedent, analyzing the information and providing actionable regulatory intelligence.


Kimberly Belsky, MS, senior director, regulatory policy and intelligence, Mallinckrodt Pharmaceuticals
Linda Bowen, MS, RAC, FRAPS, senior director, US regulatory science and policy, Sanofi
João Duarte, associate director, Europe regulatory policy and intelligence, Takeda
Robert Kester, associate director, regulatory affairs international, Merck
Matt Medlin, manager, US regulatory affairs, R&D Pipeline, Chiesi
James Monroe, MS, RAC, CQA, director of regulatory affairs, Pentax Medical


1:15–2:45 pm

Does Your Firm have Issues With Data Integrity? Red Flags Investigators Look For

During drug and device inspections, investigators may ask about the systems your organization uses to ensure the accuracy and consistency of its data. When firms fail to have a system, or the system is inadequate, FDA officials issue 483 observations or send warning letters. During this high-energy interactive session, you will learn why FDA has started to focus on data integrity. You will also hear about key guidance documents, and actions you can take to ensure the integrity of your data. Additionally, you will learn about the red flags that FDA investigators are trained to look for.

John Avellanet, FDA compliance expert, managing director and principal consultant, Cerulean Associates LLC
Nancy Singer, JD, LLM, RAC, FRAPS, president, Compliance-Alliance
Robert Tollefsen, national expert investigator for computer systems, Division of Field Investigations, ORA/FDA