20th Annual Pharmaceutical and Medical Device Compliance Congress
WHEN: Wednesday, November 6, 2019 – Friday, November 8, 2019
WHERE: Mandarin Oriental – 1330 Maryland Avenue SW, Washington DC
Speakers:
- Sarah diFrancesca
Day 2 – Thursday, November 7, 2019
Mini Summit VIII: Lessons Learned from Enforcement Actions
Mini Summit XXVII: Interactions with Specialty Pharmacy - Wendy Goldstein
Day 2 – Thursday, November 7, 2019
Mini Summit XVI: How do you Modernize your Compliance Program to Prepare for the Future of Health?
What is it about?
Cooley is sponsoring the 20th Annual Pharmaceutical and Medical Device Compliance Congress. Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from 50+ of the largest research-based pharmaceutical manufacturers.
Event details and registration
CBI’s 4th Edition Drug Pricing Transparency Congress
WHEN: March 25, 2019 – March 26, 2019
WHERE: The Bellevue Hotel – 200 South Broad Street, Philadelphia, PA
Speakers:
- Sarah diFrancesca
Partner
Cooley LLP
What is it about?
The future of drug pricing transparency regulations impacting commercialization, reimbursement, pricing and compliance practices. Learn what is driving the new laws of 2019 and proposed objectives of the legislation to grasp best practices and implement strategic steps.
Event details and registration
New York Health Business Leaders
Healthcare Investment Trends: Where Will the Money Flow in 2019?
WHEN: Thursday, February 7, 2019 5:30PM – 7:30PM
WHERE: Harvard Club – 35 West 44th Street, New York, NY
What is it about?
Cooley is a corporate sponsor of New York City Health Business Leaders. This event is their most popular of the year, bringing together a panel of healthcare investors to discuss where the healthcare dollars will flow. Fresh off the heels of JP Morgan, you’ll hear insights and perspectives from speakers who fund companies across the healthcare spectrum.
Event details and registration
Discussion of the Current Washington Landscape and Potential Effects for Healthcare and Life Sciences Companies
WHEN: Tuesday, January 8, 2019
WHERE: Le Meridien 333 Battery Street, San Francisco, CA
Speakers:
- Wendy Goldstein
Partner
Cooley LLP - Vince Sampson
Special Counsel
Cooley LLP
What is it about?
The 2018 midterm election results ushered in a dividend government in Washington, DC. Healthcare was one of the key issues for many voters, which will make it a priority for both Chambers of Congress. Prescription drug prices, 340B program reform, addressing innovation in the regulatory process, removing regulatory barriers and strengthening the Affordable Care Act are among topics facing Congress and the Administration.
Please join us for a discussion of how the healthcare and life science industries could be impacted by legislative and oversight agendas, the outlook for regulations and the possibility of cooperation between Capitol Hill and 1600 Pennsylvania Ave.
For more information, please email Amanda Richardson at arichardson@cooley.com or call +1 617 937 2460.
CBI’s 2018 PAP Legal Update:
Address Compliance Risks to Ensure Sustainable Patient Programs
WHEN: Tuesday, September 25, 2018
WHERE: Westin Arlington Gateway – 801 N Glebe Road Arlington, VA
Speakers:
- Sarah diFrancesca
Partner
Cooley LLP
What is it about?
CBI’s 3rd Annual PAP Legal Update Forum brings together industry thought leaders, government stakeholders, non-profit organizations and advocacy groups to discuss the most pressing compliance challenges.
Event details and registration
CBI’s Drug Pricing Transparency Congress
WHEN: Thursday, September 27, 2018 • 7:30 am – 5:00 pm
WHERE: The Bellevue Hotel – 200 South Broad Street, Philadelphia, PA
Speakers:
- Sarah diFrancesca
Partner
Cooley LLP - Vince Sampson
Partner
Cooley LLP
What is it about?
State drug pricing regulations remain in the headlines as state legislatures continue to introduce and pass laws aimed at transparency and reporting obligations leaving a myriad of legal and compliance complexities. Over the past year, states including Oregon, California, Nevada, Maryland, New York, Massachusetts and Vermont have introduced and/or enacted different laws and enforcement initiatives mandating the disclosure of drug pricing increases, introducing restrictions limiting Medicaid drug spending, requiring disclosure of company metrics and expenses, and other related pricing ballot initiatives.
Event details and registration
Let’s Talk Compliance Series:
How Do We Ensure The Success of Our Compliance Efforts?
WHEN: Wednesday, October 3, 2018 • 5:30 pm – 7:00 pm
WHERE: Local Kitchen & Wine Merchant – 330 1st Street San Francisco, CA
Speakers:
- Wendy Goldstein
Partner
Cooley LLP - Sarah diFrancesca
Partner
Cooley LLP
What is it about?
Cooley’s Let’s Talk Compliance Series is a private, invitation only series that allows life sciences companies with newly launched compliance functions to discuss strategies and better practices for ensuring its success. This multi-part series will cover trending compliance topics in a conversational and relaxed atmosphere.This session will focus on patient assistance programs and will include a discussion of the legal parameters, recent enforcement activity and compliance tips for ensuring that your compliance is ready for success.
Future Let’s Talk Compliance Series topics will include:
- Patient advocacy interactions
- Federal and state “sunshine” laws
- Drug pricing and pricing transparency
For more information, please email Amanda Richardson or call +1 617 937 2460.
19th Annual Pharmaceutical and Medical Device Compliance Congress
WHEN: Wednesday, November 7, 2018 – Friday, November 9, 2018
WHERE: Mandarin Oriental – Maryland Avenue SW, Washington, DC
Speakers:
- Wendy Goldstein
Partner
Cooley LLP - Sarah diFrancesca
Partner
Cooley LLP
What is it about?
Cooley is sponsoring the 19th Annual Pharmaceutical and Medical Device Compliance Congress. Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from 50+ of the largest research-based pharmaceutical manufacturers.
Event details and registration
CBI’s 2017 PAP Legal Update: Navigate Legal Challenges to Build Sustainable Patient Programs
WHEN: September 25-26, 2017
WHERE: The Westin Arlington Gateway – 801 North Glebe Road, Arlington, VA 22203
Speaker
- Sarah K. diFrancesca
Partner
Cooley LLP
What is it about?
CBI’s 2017 PAP Legal Update will provide critical insight into key legal issues, including recent advisory opinions from the OIG, sustainable funding models, and opportunities for industry collaboration in the face of an increased need for risk mitigation.
- Prepare for the future with a detailed analysis of recent OIG Advisory Opinions
- Learn about how changes in healthcare reform may affect PAPs moving forward
- Enhance your strategies for patient assistance for Medicare Part D patients
- Analyze opportunities for improved communication and collaboration between PAP foundations and manufacturers
- Examine the relationship between programs for uninsured and underinsured to enhance prospects for patient access
- Hear from industry and legal experts on advancing programs despite legal uncertainty
- Discuss best practices and case studies with stakeholders across the PAP space
Event details and registration
18th Annual Pharmaceutical and Medical Device Compliance Congress
WHEN: November 6 – 8, 2017
WHERE: Mandarin Oriental, Washington DC – 1330 Maryland Ave SW, Washington DC 20024
Speakers
- Wendy Goldstein
Partner
Cooley LLP - Sarah diFrancesca
Partner
Cooley LLP
What is it about?
The purpose of the Pharmaceutical Compliance Forum is to discuss education and other industry practices regarding compliance with the ultimate aim of promoting effective pharmaceutical corporate compliance and ethics programs in accordance with the Federal Organization Sentencing Guidelines and the OIG Compliance Guidance for Pharmaceutical Manufacturers.
Event details and registration
The Future of New York Healthcare: Where Are We and What Happens Next?
WHEN: June 14, 2017 at 5:30pm EST
WHERE: Cooley LLP, 1114 Avenue of the Americas, 46th Floor
Moderator
- Wendy Goldstein
Partner
Cooley LLP
Speakers
- Amanda Parsons, MD
Vice President, Community & Population Health
Montefiore Health System - Dan McCarthy
President & Chief Operating Officer
Healthfirst - Joseph Conte
Executive Director
Staten Island Performing Provider System - Mario Schlosser
CEO and Co-Founder
Oscar
For more information or to register, please click here.
Regulatory Roundtable Immersion Series – Session #13: State of the Healthcare Union: A Review of 2016 Key Events, A Look Into The 2017 Healthcare Agenda and Practical Tips for Living in Current Times
WHEN: April 25, 2017 at 5:30pm PST
WHERE: Cooley LLP, 3175 Hanover Street, Palo Alto, CA
Speakers
- Wendy Goldstein
Partner
Cooley LLP (New York, NY) -
Sarah diFrancesca
Partner
Cooley LLP (New York, NY)
What is it about?
- Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide insight, real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
For more information, please email Leah Lowery at llowery@cooley.com.
FDLI’s Introduction to U.S. Biologics and Biosimilars Law and Regulation
Regulation of Biological/Drug Development
WHEN: March 15, 2017 at 1:00pm EST
WHERE: Arnold & Porter Kaye Scholer, 601 Massachusetts Ave NW, Washington, DC 20001
Speakers
-
Natasha Leskovsek
Partner
Cooley LLP (Washington, DC)
For more information or to register, please click here.
ACI’s 17th Annual Conference on Fraud and Abuse in the Sale and Marketing of Drugs, Devices, and Medical Technology
Pricing Considerations for the Compliance Agenda in an Evolving Environment
WHEN: March 6, 2017 at 4:30pm EST
WHERE: Omni Parker House, 60 School Street, Boston, MA 02108
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY) -
David Ralston
Senior Director, Associate General Counsel, Business Conduct
Gilead Sciences
What is it about?
- Update on industry activity
- Better practices to manage pricing, reimbursement support, copay mitigation, and charitable foundation relationships
- Trends in state law pricing transparency
- Developing a relevant oversight agenda for your organization on key relationships that impact pricing
For more information or to register, please click here.
Regulatory Roundtable Immersion Series – Session # 12: What to Expect in Health Policy Under the 115th Congress and New Presidential Administration
WHEN: February 1, 2017 at 6:00pm PST
WHERE: Cooley LLP, 3175 Hanover Street, Palo Alto, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY) -
Vince Sampson
Special Counsel
Cooley LLP (Washington, DC)
What is it about?
- Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide insight, real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
NYCHBL’s Privacy Please: How Healthcare is Managing Cyber Risk
WHEN: December 13, 2016 at 5:30pm EST
WHERE: Cooley LLP, Grace Building, 1114 Avenue of the Americas, New York, NY 10036
Moderator
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
Speakers
- Asaf Evenhaim
CEO
Crossix
-
Edward Glynn
Principal
Ernst & Young
- Andy Roth
Partner
Cooley LLP (New York, NY)
-
Brian Smith-Sweeney
CISO
Columbia University Medical Center
What is it about?
- What is keeping healthcare CEOs up at night? The threat of cyber attacks. Cybersecurity is one of the most critical issues facing healthcare executives across the ecosystem. From HIPAA breaches to medical identity theft to safeguarding intellectual property, protection from cyber attacks has become an urgent imperative. On October 27, Cooley will host a panel discussion on cybersecurity that will cover the current legal, regulatory, business, and technological environment, and explore options for effective management for senior management and boards of directors.
Please register here.
ACI’s 16th Annual Drug Pricing Master Course
Developing a Culture of Pricing Compliance – Strategies for Avoiding OIG and DOJ Scrutiny of Drug Pricing Practices
WHEN: November 2, 2016 at 3:45pm EST
WHERE: Park Lane Hotel, 36 Central Park S, New York, New York 10019
Speakers
-
William Davis
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Washington, DC) -
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
What is it about?
- Understanding the current environment for compliance and enforcement related to pricing issues
- Identifying compliance guidance for pricing issues
- Anatomy of a government False Claims Act and Anti-Kickback investigations
- Identifying the roles of CMS, OIG and DOJ relative to pricing, rebates and enforcement
- Acknowledging the OIG’s direct pricing authority to determine and force WAMP (widely available market price) as an alternative to ASP
- Comprehending the OIG’s indirect impact on pricing
- Coupons
- Part D rebates and administrative fees
- Assessing potential anti-kickback violations with treatment of payment support programs for price reporting
- Bolstering compliance programs and internal practices to minimize the risk of investigations
- Analyzing enforcement trends
- False claims act cases
- Bundling cases
- Responding to government investigations
- Assessing the collateral consequences of investigations
Please register here.
The Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress
R&D Compliance: Introduction, Panel Discussion and Q&A
WHEN: October 20, 2016 at 10:30am EST
WHERE: Mandarin Oriental, 1330 Maryland Avenue SW, Washington, D.C.
Moderator
- Daniel A. Kracov
Partner and Head, FDA and Healthcare Practice
Arnold & Porter (Washington, D.C.)
Speakers
-
Natasha Leskovsek
Partner
Cooley LLP (Washington, D.C.) -
Sue Seferian
Global R&D Health Care Compliance Office
Johnson & Johnson (New Brunswick, NJ)
- Michelle Shwery
Senior Advisor, Ethics and Compliance, Eli Lilly and Company, Indianapolis, IN
Eli Lilly and Company (Indianapolis, IN)
What is it about?
- The Pharmaceutical Compliance Forum (PCF) is a coalition of senior compliance professionals and legal counsel from more than 50 of the largest research-based pharmaceutical manufacturers.
Learn more about the event here.
CLSA’s Inaugural Corporate Counsel Committee Meeting Featuring Cooley’s Regulatory Roundtable Immersion Series – Session #11
WHEN: October 19, 2016 at 5:30pm PST
WHERE: Cooley LLP, 3175 Hanover Street, Palo Alto, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY) -
Natasha Leskovsek
Partner
Cooley LLP (Washington, D.C.)
What is it about?
- Cooley is sponsoring CLSA’s inaugural Corporate Counsel Committee meeting on October 19 and will feature Regulatory Immersion Roundtable Series, session# 11 led by Cooley partners Wendy Goldstein and Natasha Leskovsek.
- Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization. All CLSA members interested in joining the committee are invited to attend.
Regulatory Roundtable Immersion Series – Session #10: Who Dun It? Conducting Effective Internal Compliance Investigations
WHEN: August 9, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY) -
Sarah diFrancesca
Associate
Cooley LLP (New York, NY)
What is it about?
- Cooley’s Regulatory Roundtable Immersion Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #9: Now Hear This – Promotional Compliance Considerations in an Evolving Environment
WHEN: April 19, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
-
Sarah diFrancesca
Associate
Cooley LLP (New York, NY)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Seton Hall’s Life Sciences Compliance Program – West Coast Immersion
WHEN: March 21, 2016 – March 23, 2016
WHERE: The Marker San Francisco, 501 Geary Street, San Francisco, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
-
Sarah diFrancesca
Associate
Cooley LLP (New York, NY)
What is it about?
-
This three-day educational program immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as “fraud and abuse law,” as well as other healthcare-related laws and regulations, to help the audience understand the legal underpinnings of the life sciences compliance education programs they develop and enforce. Click here for more information.
Regulatory Roundtable Immersion Series – Session #8: To Infinity and Beyond: A Discussion of the Hot Topics Inside the Beltway and how they could Impact your Company
WHEN: February 24, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY) -
Vince Sampson
Special Counsel
Cooley LLP (Washington, DC)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #7: Do Not Enter: Privacy & Security for Life Sciences Companies
WHEN: January 19, 2016 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY) -
Phil Mitchell
Special Counsel
Cooley LLP (New York, NY)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #6: Knock, Knock: Government Investigations & Inquiries
WHEN: November 10, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #5: How To Get Paid: Coverage, Reimbursement & Pricing
WHEN: October 7, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
-
Lila Hope
Partner
Cooley LLP (Hanover, CA)
-
Kathleen Peterson
Special Counsel
Cooley LLP (Washington, DC)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #4: SPF 50: Federal and State Sunshine Laws
WHEN: September 2, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
-
Danielle Naftulin
Partner
Cooley LLP (Hanover, CA)
-
Sarah diFrancesca
Associate
Cooley LLP (New York, NY)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #3: Sleepless Nights: Which Health Care Laws (Should) Keep You Up At Night?
WHEN: June 22, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #2: House of Card: How To Build An Effective Corporate Compliance Program For Your Organization
WHEN: May 14, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
-
Lila Hope
Partner
Cooley LLP (Hanover, CA)
-
Danielle Naftulin
Partner
Cooley LLP (Hanover, CA) - Sarah diFrancesca
Associate
Cooley LLP (New York, NY)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.
Regulatory Roundtable Immersion Series – Session #1: Board Talk: How To Address Health Care Compliance With The Board Of Directors
WHEN: April 14, 2015 at 6:00pm PST
WHERE: John Bentley’s Restaurant, 2915 El Camino Real, Redwood City, CA
Speakers
-
Wendy Goldstein
Partner
Cooley LLP (New York, NY)
-
Lila Hope
Partner
Cooley LLP (Hanover, CA)
-
Sarah diFrancesca
Associate
Cooley LLP (New York, NY)
What is it about?
-
Cooley’s Regulatory Immersion Roundtable Series is an invitation-only series for senior company executives and investors. It is designed to provide real-life examples and practical tips for addressing the most significant legal and compliance topics relevant to pharmaceutical, biotechnology and medical device companies in late stage development or early commercialization.