Life Science Compliance Update

Upcoming Compliance Conferences

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March 2018

Mon 26 - Tue 27Mar2018

2nd Product Complaints Forum

Attendees will have the unique opportunity to learn from and network with our speaking faculty of medical device, pharmaceutical, and biotech industry leaders, who will share their years of knowledge and experience handling product complaints. Our experts will be discussing the industry's most pressing challenges, including FDA guidances and the impact of FDA rulings, audit preparation, utilizing social media in your complaint program, combination products, and much more! Join your peers to share best practices and learn new, innovative ways to make your complaint management system more effective.

Location: Philadelphia, PA

Organiser: ExL Events

April 2018

Wed 11 - Thu 12Apr2018

8th Global Transparency Reporting Congress

Now in its 8th year, CBI’s Global Transparency Reporting Congress serves as the go-to global event for compliance professionals and offers critical insights for maintaining a globally compliant culture for transparency of HCP/HCO spend across the organisation as well as transforming the ethics of the organisation.

Location: London, UK

Organiser: CBI

Mon 23 - Wed 25Apr2018

CBI: PCC 2018 – The 15th Annual Pharmaceutical Compliance Congress

PCC 2018 is the industry’s gold standard for compliance excellence, attracting more than 500 industry leaders annually. Join us in April, when the brightest minds and most influential stakeholders in life sciences compliance unite with an unmatched speaking faculty, meaningful networking and strategic content.

Location: Washington, DC

Organiser: CBI

Mon 23 - Wed 25Apr2018

Paragraph IV Disputes

Meet and network with the key influencers shaping the law, policy and proceedings of Paragraph IV litigation. Each spring, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes conference to discuss, debate, and analyze the latest trends, judicial rulings and legislative developments affecting Hatch-Waxman litigation. As the industry prepares to address the fall out of global pharmaceutical patent losses of billions of dollars on the Hatch-Waxman landscape, the time for this conference has never been more relevant.

Location: Conrad New York, New York, NY

Organiser: American Conference Institute

May 2018

Thu 03 - Fri 04May2018

5th Annual FMV Congress

Elevate Best Practices in Fair Market Value Calculations to Ensure Compliance CBI’s 5th Annual FMV Congress delves into the complexities of FMV management to improve compliance and elevate HCP relationship management. This program promotes a deeper understanding of the risk factors when establishing a compliant and global FMV program, as well as best practices for calculations and tiering. This program promotes a deeper understanding of the risk factors involved in establishing a compliant FMV program, including best practices for calculations and tiering. This comprehensive conference will address crucial topics and challenges such as understanding the cross-border complexities of HCP engagements, FMV of clinical trials and internal cohesion regarding FMV processes, documentation and compliance.

Location: Philadelphia, PA

Organiser: CBI

Mon 14 - Wed 16May2018

Twelfth International Pharmaceutical and Medical Device Compliance Congress

Location: Hotel Savoyen, Vienna, Austria

Organiser: Sponsored by International Society of Healthcare Compliance Professionals (ETHICS)

Thu 17 - Fri 18May2018

5th Promotional Review Committee Compliance & Best Practices – Midwest

ExL Events invites you to the 5th annual Promotional Review Committee Compliance & Best Practices – Midwest conference — the only industry event devoted entirely to optimizing the roster, skill sets, teamwork, and speed of your PRCs. No other event goes into as much depth on these essential skills!

Location: Conrad Chicago, Chicago, IL

Organiser: ExL Events

Mon 21 - Wed 23May2018

20th Annual Medicaid and Government Pricing Congress

Dynamic Dialogue Through Timely Updates and Unparalleled Insights for Strategic and Operational Excellence Celebrating 20 years of high-quality content, CBI’s Medicaid and Government Pricing Congress remains the most dynamic and concentrated event for executives working within the government pricing and reporting arena. This conference arms attendees with action-oriented discussions on a full range of content including 340B reform, state price transparency and reporting, FSS contracting, value-based frameworks, Medicare reimbursement and much more. Year over year, hundreds mark this event as a must attend!

Location: Orlando, FL

Organiser: CBI

Mon 21 - Tue 22May2018

2018 Off-Label Regulatory Compliance Congress

The 2018 Off-Label Regulatory Compliance Congress also explores the ever-changing regulatory landscape and explains how professionals can work with officials to ensure that promotional practices remain compliant and expedite the transmission of relevant scientific information to advance public health.

Location: Hilton Washington Dulles Airport

Organiser: ExL Events

Tue 22 - Wed 23May2018

U.S.-Based Global Transparency Reporting

CBI’s first U.S. based Global Transparency Reporting congress offers a unique opportunity for compliance professionals to examine the latest trends, challenges and solutions for negotiating the dynamic global transparency reporting environment. This highly, interactive dialogue features case studies, panels and facilitated breakout sessions addressing the latest developments in transparency reporting around the globe and what is really required to comprehensively manage HCP interactions.

Location: Orlando, FL

Organiser: CBI

Tue 22 - Wed 23May2018

Life Sciences & Healthcare Qui Tam and False Claims Summit

False claims enforcement in the healthcare industry has substantially increased in the last few years and is expanding from pharmaceutical companies and medical devices to physician groups, nursing homes, rehabilitation facilities, medical records, managed care and hospitals. The U.S. Supreme Court’s 2016 Escobar decision substantially altered the use of implied certification lawsuits and recently lower courts are split on the interpretation of materiality and falsity. Today, there continues to be increased activity in investigations of new and existing potential false claims cases regardless of whether the government decides to intervene. Based on popular demand, American Conference Institute presents the inaugural Life Sciences & Healthcare Qui Tam & False Claims Summit, which will focus exclusively on life sciences and healthcare industry.

Location: The Harmonie Club, New York, NY

Organiser: American Conference Institute

Wed 30 - Thu 31May2018

Pharmaceutical Compliance Congress Latin America

Pharmaceutical, biotech and medical device companies in Latin America are stepping up to combat bribery and corruption challenges. In an era of emerging compliance risks and political unrest, it is critical that life sciences organizations develop robust and tailored third-party and distributor management programs along with continuous risk-based audition and monitoring of third-parties. Join us this May at CBI’s PCC Latin America to strengthen compliance programs, increase transparency and commit to a culture of ethics.

Location: Panama City, Panama

Organiser: CBI

Thu 31May2018
Fri 01Jun2018

12th Annual “BIG 4” Pharmaceutical Pricing Boot Camp

ACI’S “BIG FOUR” PHARMACEUTICAL PRICING BOOT CAMP is an intensive training course designed to provide you with a complete understanding of core pricing competencies. ACI has assembled a faculty of top government authorities on “Big Four” pricing and pharmacy benefits programs along with expert pricing practitioners. This distinguished faculty will make sense of complicated terminology and pricing calculations and teach you how to navigate the complexities of working with the “Big Four” agencies. By providing solutions for the calculation, contracting and operational challenges many manufacturers face as a result of federal pricing, this conference will allow those in the industry to work more effectively with the “Big Four” agencies. This unique opportunity to have your questions answered directly by the government agencies administering federal payor programs will prove invaluable when trying to improve and streamline practices.

Location: The InterContinental New York Times Square, New York, NY

Organiser: American Conference Institute

June 2018

Tue 05 - Thu 07Jun2018

Pharmaceutical Compliance Congress Canada

On the heels of our highly-acclaimed inaugural event, CBI’s 2nd Annual Pharmaceutical Compliance Congress Canada convenes top Canadian compliance practitioners and leading experts to discuss effective strategies to achieve organization-wide compliance, from the compliance and legal teams to the oversight of the promotional marketing and sales teams. Join your Canadian colleagues for robust conversations on the top issues facing industry today.

Location: Toronto, Canada

Organiser: CBI

Mon 11 - Tue 12Jun2018

9th Aggregate Spend and Open Payments Conference

This event will bring together professionals from across the compliance landscape to discuss past submissions and upcoming changes in order to better prepare their company’s reporting processes. Attendees will explore compliance theories about how to match transparency-reporting processes with continually evolving business systems and promotional activities, develop a framework for compliance in emerging markets, and more.

Location: Philadelphia

Organiser: ExL Events

Tue 12 - Wed 13Jun2018

Compliance Congress on Non-Promotional Activities

CBI’s Bio/Pharma Compliance Congress on Non-Promotional Activities offers an unparalleled agenda delivered by the industry’s leading experts. During this meeting, navigate medical affairs complexities and shine light on R&D compliance to propel scientific exchange in a time of increased scrutiny. Collaborate with your peers to zero in on prevailing industry approaches to advance your company’s compliance efforts and return with clear strategies to navigate the gray area between clinical and commercial to ensure compliance enterprise-wide.

Location: Philadelphia, PA

Organiser: CBI

Mon 18 - Wed 20Jun2018

Legal, Regulatory and Compliance Forum on Dietary Supplements

American Conference Institute (ACI) together with the Council for Responsible Nutrition (CRN) invite you to attend ACI’s 6th Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. This “must-attend” event for the legal, regulatory and compliance stakeholders of the dietary supplement industry will not only provide “state of the union updates”, but also allow for the opportunity to discuss and assess the politics and policy shaping the industry’s current political, legislative, and regulatory atmosphere.

Location: Intercontinental New York Times Square, New York, NY

Organiser: American Conference Institute

Mon 25 - Tue 26Jun2018

Summit on Biosimilars

Discuss the future of biosimilars and formulate solutions to the complex regulatory and patent challenges ahead with industry leaders from both innovator and biosimilar companies. Featured sessions for our 2018 event include topics such as: · - Practical patent dance experience and strategies post Sandoz v. Amgen · - Addressing and overcoming barriers to biosimilar development and launch · - Judges’ panel of inside perspectives on biosimilar litigation · - Updates on naming and labeling requirements for both innovator and biosimilar products · - Drug costs and reimbursement

Location: InterContinental New York Times Square, New York, NY

Organiser: American Conference Institute

July 2018

Wed 25 - Fri 27Jul2018

Women in Life Sciences Law

Increasing the Prominence of Women in the Life Sciences Legal Community through Substantive Legal Discussion, Professional Development, and Woman-to-Woman Networking. Each year, nearly 200 professionals attend this annual event specifically designed for women life sciences practitioners to discuss the challenges and opportunities facing women in this industry, as well as to foster communication between like-minded individuals about the key legal developments for pharmaceutical, biotech, and medical device companies in the life sciences world. All presentations, a mixture of both professional development and substantive legal topics, are tailored to empower women in this space and to give women the skills necessary for continued success in the life sciences world.

Location: Hyatt Regency Boston, Boston, MA

Organiser: American Conference Institute

Mon 30 - Tue 31Jul2018

Drug & Medical Litigation Boot Camp

From the creators of the annual December Drug and Med conference, that has been the industry’s premier products liability litigation event for the last 22 years, comes its summer companion: Drug and Med Litigation Boot Camp. Benchmark your advocacy strategy, settlement, and pre-trial tactics at the ultimate litigation boot camp for pharmaceutical and medical device manufacturers and their counsel. Drawn from one central adverse event fact pattern to be provided to attendees shortly before the conference, this event will provide a two-day mock experience detailing actual settlement negotiation, pre-trial and trial strategies as taught by the top in-house as well as outside counsel negotiators and litigators in the country. Each segment will be evaluated by the judges currently sitting on the bench as well as the attendees who will have an opportunity to interact with presenters and judges throughout the event.

Location: Philadelphia, PA

Organiser: American Conference Institute

August 2018

Mon 20 - Wed 22Aug2018

12th Annual Forum on Transparency and Aggregate Spend

Transparency and Aggregate Spend 2018 serves as the largest and most essential meeting place for pharma, biotech and medical device professionals to stay up to date with the increasingly complex state and local regulations, as well as federal and emerging global regulations for HCP spend reporting.

Location: Washington, DC

Organiser: CBI

September 2018

Mon 10 - Wed 12Sep2018

8th Asia Pacific Pharmaceutical and Medical Device Compliance Congress

Location: Shangri-La Hotel Singapore

Organiser: Sponsored by Asia Pacific Healthcare Industry Compliance Team; Cosponsored by International Society of Healthcare Ethics and Compliance Professionals

November 2018

Wed 07 - Fri 09Nov2018

19th Annual Pharmaceutical and Medical Device Compliance Congress

A Hybrid Conference and Internet Event Transformational Learning - Effective Knowledge Exchange

Location: Mandarin Oriental Washington, DC

Organiser: Sponsored by Pharmaceutical Compliance Forum - Media Partners: Harvard Health Policy Review, Health Affairs and Life Sciences Compliance

Wed 28 - Fri 30Nov2018

23rd Annual Conference on Drug & Medical Device Litigation

Widely regarded as the go to annual conference for the pharmaceutical and medical device products liability community, ACI’s Drug and Med event is the only truly forward-looking think tank event that brings together the judges, government enforcers, in-house counsel, and outside counsel to discuss not only the most pressing issues affecting pharma and device industries today but also where they see these industries heading!

Location: New York Marriott Marquis, New York, NY

Organiser: American Conference Institute


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