Pharmaceutical Internal Investigations Preparation and Management Forum

Transcription

1 Pharmaceutical Internal Investigations Preparation and Management Forum Proactive Strategies for Cross-Functional Collaboration to Quickly and Thoroughly Manage an Investigation May 5-6, 2014 Hyatt at the Bellevue Philadelphia, PA Featured Speakers Jeffrey Antoon, Internal Audit Director, Johnson & Johnson Josh Axelrod, Compliance Counsel, Jazz Pharmaceuticals Jennifer L. Bragg, Partner, Health Care Enforcement and Litigation, Skadden, Arps, Slate, Meagher & Flom LLP & Affiliates Joseph Cacciatore, Executive Director, Ethics and Compliance, Monitoring and Investigations, Novartis Erin Carducci Monaco, PharmD, DRA Advertising & Promotion Review - MS Lead, US Medical, Novartis Pharmaceuticals Corporation Kristina O. Cronk, Director, Employee Relations & Compliance, Boehringer Ingelheim Diane DeLoria, Health Care Compliance Officer, Pharm Group Health Care Compliance, Johnson & Johnson Hardin B. Kimmel, Director, Ethics and Compliance, Medtronic Spinal Michael McCann, Compliance Director, Abbott Laboratories Jeffrey Scott, Senior Corporate Counsel, Pfizer, Inc. Peter Viksnins, Director, PricewaterhouseCoopers LLP Jim Vollins, Vice President, Sr. Assistant General Counsel, Grifols Therapeutics Inc. Raymond S. Wysmierski, Associate Director, Investigations, Training and Corrective Actions, UCB, Inc. Find Out How To Develop A framework to quickly triage and assess an incoming allegation and assign it to the appropriate skillset Create A culture that encourages employees to report misconduct to better protect the company Ensure Mechanisms are in place to detect and mitigate off-label promotion to avoid an investigation Overcome Challenges of international investigations including data privacy laws and language barriers Conduct A risk profile and understand which areas warrant the highest risk for your organization and put monitoring in place to identify potential misconduct Pre-Conference Workshop Are You Ready for a Crisis? Crisis Management Strategies for the Senior Leadership Team Gain an action plan for the cross-functional leadership team to cascade a company-wide action plan to set up a crisis management team, develop a crisis communication plan and be prepared to manage and face the media and key stakeholders. Workshop Leader Cherif Benattia MD, President and CEO, APhaRC, LLC Sponsor: To Register: Call Visit

2 About every 30 hours, throughout the year, we are gaining a conviction, in crimes ranging from street level pharmaceutical diversion schemes to corporate fraud. John Roth, Director, FDA s Office of Criminal Investigations, July 24, 2013 From the domestic to the international sphere, investigations are rampant across the industry costing companies billions of dollars in lost revenue as well as tarnishing well-established brands. Whistleblowers in the US making allegations against pharmaceutical companies bring in billions of dollars annually to the Department of Justice. Furthermore, a recent top pharma company saw revenue plummet by 61% in China on the backs of a bribery probe. What are the real costs of an investigation to your company? Are you confident that you can swiftly and thoroughly manage an investigation within a cross-functional team? Internal investigations are by definition of an urgent and sensitive nature, requiring maximum coordination across multiple divisions. ExL Pharma s Pharmaceutical Internal Investigations Preparation and Management Forum will provide a two-part strategy outlining the methodologies to be prepared for and prevent investigations and the framework necessary to manage the day-to-day demands when an investigation strikes. Day 1 Focus Prepare for and prevent investigations by: Implementing robust monitoring procedures to identify red flags and overcome challenges of monitoring communications off the system Ensuring comprehensive systems are implemented to detect and mitigate off-label promotion Developing a company culture that encourages and reassures employees to report misconduct Day 2 Focus Quickly and compliantly manage investigations by: Handling incoming tips and quickly assigning each to the appropriate skillset Managing the internal information flow to senior management, HR and the working group Knowing when to report, and what and how much to say when reporting to government agencies Overcoming the complex challenges of international investigations, from maintaining compliance with data privacy laws to overcoming language barriers The time for planning is now. Return with a toolkit of strategies for prevention, preparation and management. Implement a framework to encourage reporting, update monitoring points, detect off-label promotion, triage tips and assign leads, compliantly report to agencies, keep all cross-divisional players up-to-date and know how Who Should Attend Representatives from pharmaceutical, biotechnology and medical device companies responsible for: Investigations Security Legal Global and Corporate Compliance Internal Audit Venue HR Ethics Business Conduct and Investigations Regulations Hyatt at the Bellevue 200 South Broad Street Philadelphia, PA If you require overnight accommodations, please contact the Hyatt at the Bellevue at to book your room. ExL has reserved a block of rooms at a discounted rate for conference participants. Please mention ExL s March Meeting to take advantage of the discount. You must book your room by February 10, 2014 to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate are limited. Sponsorship & 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. To learn more about these opportunities, please contact: Andrew Ferguson Business Development Manager (917) aferguson@exlpharma.com

3 Day One May 5, 2014 Pre-Conference Workshop 8:30 Registration and Continental Breakfast for Workshop Participants 9:30 Pre-Conference Workshop Begins 12:30 Lunch for Workshop Participants Cherif Benattia, MD brings over 25 years of experience in the pharmaceutical industry with solid expertise in Pharmacovigilance, Risk Management, Risk and Crisis Communication and Management. After being the Head of Medical Surveillance and Risk Management at Sunovion Pharma for the last couple of years, he is back to consulting and managing his company APhaRC, LLC, Patient Safety First. Before Sunovion Pharmaceuticals, Dr. Benattia worked as VP, Patient Safety and Pharmacovigilance at Vertex and before that he held different senior positions at J&J (VP, BRM), Pfizer and Zeneca. Dr Benattia has also worked closely with the FDA, Bio and MIT CBI on numerous projects like the Sentinel Initiative and the Framework for Risk Benefit Management. He is a frequent guest speaker throughout the world and teaches at Paris VI University and at the ESSEC business school on Risk Management and Crisis Communication/Management. Are You Ready For a Crisis? Crisis Management Strategies for the Senior Leadership Team Crises could hit a company and damage its reputation at any time, anywhere and often occur when they are least expected. When a crisis does occur, events usually unfold rapidly, leaving little time for planning and managing properly. Communication is one of the biggest challenges during a crisis. Advance preparation is crucial and appropriate crisis communication and management plans will help minimize the effects of a crisis and sometimes have a positive impact. This workshop will help you to: Understand the basics of crisis communication and crisis management Be able to set up a crisis management team Develop a company wide crisis communication plan and procedures Be better prepared to face and manage the media Know how to handle corporate relations, media partners and key stakeholders Be perceived as trustful, credible and professional Be ready and better prepared for your next crisis Workshop Leader Cherif Benattia MD, President and CEO, APhaRC, LLC Day One May 5, 2014 Main Conference: Preparation & Prevention 12:30 Registration Opens for Conference Attendees 1:30 Chairperson s Day One Welcome and Opening Remarks 1:45 Overview of the Latest Areas the DOJ is Scrutinizing Know what is coming under fire at the DOJ from new trends in misbranding and off-label promotion to compliance with cgmps Find out about the latest cases going through the DOJ and strategize on how you would conduct investigations on these topics Ensure your drugs to be sold to the public are both safe and effective in compliance with the mission of the FDA Jennifer L. Bragg, Partner, Health Care Enforcement and Litigation, Skadden, Arps, Slate, Meagher & Flom LLP & Affiliates 2:30 Create an Environment That Encourages People to Report Ethical Misconduct Develop a company culture that will spur employees to come forward when things are going wrong Reassure employees that they will not be disciplined or reprimanded for reporting tips Provide resources and information to support the workforce to understand that incoming tips will help you to better protect the company Josh Axelrod, Compliance Counsel, Jazz Pharmaceuticals 3:15 Networking and Refreshment Break 3:45 Know Your Rights and Responsibilities Around Social Media and Off-Label Promotion to Avoid an Investigation Understand what you re responsible for when it comes to usergenerated comments online Overview of rapidly changing platforms and how to keep ahead of the curve to avoid later investigations Development of social media policies, procedures, and SOPs to be prepared Erin Carducci Monaco, PharmD, DRA Advertising & Promotion Review - MS Lead, US Medical, Novartis Pharmaceuticals Corporation 4:15 A Review of the Latest Monitoring Trends that Prompt Investigations Learn what you should be looking for in proactive monitoring reviews Know how to deal with false positives and manage the volume of issues generated to avoid interference with an effective and efficient response Understand which issues identified by monitoring programs could lead to an internal investigation Find out how to manage issues that might require investigation arising from review for Sunshine disclosure, for state law compliance, and audits Discuss challenges of monitoring communications off the system and responding to issues that are identified involving third-parties, such as contract sales representatives Tara Boyd, Senior Corporate Counsel, Compliance Division, Pfizer, Inc. Jeffrey Scott, Senior Corporate Counsel, Pfizer, Inc. 5:00 Close of Day One To Register: Call Visit

4 Day Two May 6, 2014 Main Conference: Management Strategies 8:00 Continental Breakfast for Conference Participants 9:00 Chairperson s Day Two Welcome and Day One Recap 9:15 Panel Discussion What is the Flow of Information and Trade-off When a Tip Comes In? This panel discussion will set up a realistic scenario of an incoming tip and how it is approached and managed by representatives from HR, Internal Audit, Compliance and Legal. Hear directly from these groups about what they would do and what the information and activity flow will look like to launch an investigation. Understand when and how an investigation is driven by different processes. Moderator Joseph Cacciatore, Executive Director, Ethics and Compliance, Monitoring and Investigations, Novartis Panelists Kristina O. Cronk, Executive Director, Employee Relations & Compliance, Boehringer Ingelheim Diane DeLoria, Health Care Compliance Officer, Pharm Group Health Care Compliance, Johnson & Johnson Peter Viksnins, Director, PricewaterhouseCoopers LLP 10:00 Strategies and Timelines for Handling and Managing an Incoming Tip and Assigning a Lead Triage the complaint, determine the severity and know how it must be handled, including when to get law enforcement involved Develop an actionable timeline from in point to the assignment of a lead Know the key players involved across internal audit, HR, legal and compliance and assign to the appropriate skillset developing the investigative team Raymond S. Wysmierski, Associate Director, Investigations, Training and Corrective Actions, UCB, Inc. 10:30 Develop a Cross-functional Strategy for the Internal Coordination of an Investigation Know the different responsibilities of each function across various specialties Communicate information to relevant parties while maintaining privacy and confidentiality Ensure that internal information flow to senior management and within the working group is seamless Adeptly handle questions of privilege, confidentiality, searches, conflicts of interest and ethical obligations Using third parties in your investigation Disseminating the results of your findings in an audit report Jeffrey Antoon, Internal Audit Director, Johnson & Johnson 11:15 Networking and Refreshment Break 11:45 HR Perspective Strategies for Prevention and Areas for Concern During an Investigation Coaching strategies for effective and tactful communication between management and employees Tactics for non-intimidating reporting in sensitive investigations Implement open door policies so that employees know they can be heard Know where the HR policy intersects with compliance policies and the disciplinary model Kristina O. Cronk, Executive Director, Employee Relations & Compliance, Boehringer Ingelheim 12:15 Panel Discussion Overcoming the Challenges of International Investigations What workarounds can be done to conduct an investigation while maintaining compliance with data privacy laws? What are the most effective solutions to overcoming language barriers? What forensic auditing procedures are required in an overseas investigation? What witness interview techniques will yield full disclosure and transparency? How do you prepare your senior leadership team about the challenges and costs involved with international investigations? Panelists Tiffany Benjamin, Counsel: Litigation and Legal Compliance, Eli Lilly and Company Michael McCann, Compliance Director, Abbott Laboratories Darshan Kulkarni, PharmD, MS, Esq., Principal Attorney, The Kulkarni Law Firm 1:00 Lunch 2:00 Strategies for Compliant Disclosure to Reporting Agencies Understand what to document and how and ensure speculation is eliminated and only facts are documented Strike a balance in the amount of information reported including supporting documentation and appropriate documentation Foster relationships with outside organizations including police, public prosecutors, courts and government agencies Jim Vollins, Vice President, Sr. Assistant General Counsel, Grifols Therapeutics Inc. 2:30 Closing Out an Investigation and Determining Disciplinary Actions Collaborate with HR to ensure fair and consistent treatment across the organization Know how to determine what the corrective action is based on the findings Keep a thorough record of factual documentation in support of disciplinary actions up to and including dismissal Manage internal and external public relations and circumvent potential defamation Hardin B. Kimmel, Director, Ethics and Compliance, Medtronic Spinal 3:00 Conference Concludes To Register: Call Visit

5 Registration Information Five Ways to Register ExL Events, Inc th Ave, Fourth Floor New York, NY Registration Fees Group Discount Program Save 25% Per Person When Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program. Must register four at one time. Save 15% Per Person When Registering Three Can only send three? Save 15% off of each registration. To find out more on how you can take advantage of these group discounts, please call Early Bird Pricing Register before Friday, January 31, 2014 Conference + Workshop $2,095 Conference Only $1,795 Standard Pricing Register after Friday, January 31, 2014 Conference + Workshop $2,295 Conference Only $1,995 Onsite Pricing Conference + Workshop $2,395 Conference Only $2,095 Media Partners Do you have questions or comments? Do you have any questions, comments on the program, or specific topics you would like addressed? Would you like to get involved as a speaker, moderator, or discussion leader? Please Andrew Sinetar at asinetar@exlpharma.com Payment Make checks payable to ExL Events, Inc. and write code C470 on your check. You may 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 Policy If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event: Four weeks or more: A full refund (minus a $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 issued will be $395 less. To receive a refund or voucher, please fax your request to or call 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 speakers or venue. Terms and Conditions By 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 purposes of copywriting, nor 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 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 given by any third party content provider. ExL presentations may point to 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.

6 Method of Payment: Check Credit Card Make checks payable to ExL Events, Inc. Card Type: MasterCard Visa Discover AMEX Card Number: Exp. Date: I would like to register for the conference and workshop I would like to register for the conference only Name on Card: Signature: Name: Company: Dept: Address: Title: Please contact me: I am interested in marketing opportunities at this event I wish to receive updates on ExL Pharma's upcoming events City: State: Zip: Phone: Fax: Conference Code: C470 Please Mention Priority Code Proactive Strategies for Cross-Functional Collaboration to Quickly and Thoroughly Manage an Investigation May 5-6, 2014 Hyatt at the Bellevue Philadelphia, PA With Participants From Abbott Laboratories Boehringer Ingelheim Eli Lilly Grifols Therapeutics Jazz Pharmaceuticals Johnson & Johnson Medtronic Spinal Merck Novartis Pfizer Shire UCB and more! Pre-Conference Workshop Are You Ready for a Crisis? Crisis Management Strategies for the Senior Leadership Team The urgent and sensitive nature of investigations requires a coordinated response when crisis strikes. Gain an action plan for the cross-functional leadership team to cascade a company-wide action plan for managing press enquiries, liaise with law enforcement and confidently handle corporate relations, media partners and key stakeholders Workshop Leader Cherif Benattia MD, President and CEO, APhaRC, LLC Compliance, Audit, Legal and HR professionals will help you to: Create an environment conducive to reporting potential compliance issues to avoid public whistleblowers Conduct annual high-level risk assessments to identify high areas of risk around potential FDA regulations Implement monitoring procedures to quickly identify potential schemes and issues to be mitigated Develop a cross-functional strategy to ensure internal information flow is seamless Meet the challenges of international investigations head on to maintain compliance with data privacy laws and know what forensic auditing procedures are required Pharmaceutical Internal Investigations Preparation and Management Forum Register Today ExL Events, Inc th Ave, Fourth Floor New York, NY registration@exlpharma.com