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Italian Sunshine Workshop Preview Series – Part 5
Italian Sunshine Joins the Big Leagues – What to Expect Next?
Melissa LaFrain
Global Director, Compliance & Transparency,
AstraZeneca
Ned Mumtaz
Former Director, Transparency Operations, Commercial and R&D
Pfizer | Otsuka
Marc Ussini
JOHNSON & JOHNSON
October 07th, 2024
10:00 AM – 10:30 AM EST
04:00 PM – 04:30 PM CET
About the Event:
We are honored to have an expert panel including:
Melissa LaFrain, Global Director of Compliance & Transparency at AstraZeneca, who will share her extensive experience managing compliance across 50+ countries. Melissa will walk through the techniques, tools, and processes she used to produce accurate transparency reports and secure regulatory approval across different regions.
Marc Ussini, former Commercial Expert at Johnson & Johnson, who will share the challenges he faced in preparing the first transparency report during the early days of US Sunshine Law. His real-world experience provides valuable lessons that can help you navigate the Italian Sunshine Act.
Hosted by Ned Mumtaz, former Director of Transparency Operations at Pfizer | Otsuka, who will guide the discussion, offering key insights on how to implement compliance strategies now, before official deadlines are announced.
- A comprehensive overview of the global Sunshine Law landscape, with a focus on pharmaceutical industry compliance.
- Practical techniques and tools for managing the complexities of multi-country reporting.
- Insights into the processes behind producing transparency reports that meet global standards.
- Real-world examples from Marc Ussini and Melissa LaFrain on securing regulatory approvals from leadership across different regions.
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Speakers
Melissa LaFrain
Melissa LaFrain is a seasoned compliance professional with over 10 years of experience in the life sciences industry. She has extensive expertise in operational compliance oversight, including audit, monitoring, and policy implementation. Throughout her career, Melissa has successfully established global transparency processes, streamlined disclosure reporting, and led high-performing teams. Her previous roles include positions at Wright Medical Technology, Horne LLP, and BDO Seidman LLP.
Ned Mumtaz
Former Director, Transparency Operations, Commercial and R&D Pfizer | Otsuka
Ned Mumtaz is a pharmaceutical industry veteran with 18+ years of experience. He’s held leadership roles at Schering Plough Research Inc., Wyeth Pharmaceuticals, Eisai Pharmaceuticals, and Otsuka Pharmaceuticals. A trusted consultant to 30+ drug and device manufacturers, Ned leads the compliance analytics practice and is recognized for his contributions to conferences, white papers, and webinars.
Marc Ussini
Commercial Expert Formerly with JOHNSON & JOHNSON
With over 20 years in BioPharma, Marc leads Vector Health’s compliance products and services, focusing on spend transparency. He has extensive experience from Genentech, Johnson & Johnson, and Merck & Co., and is a recognized thought leader in the field. Marc holds a degree from the University of California and a master’s in biophysics and physiology from Georgetown University.
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Italian Sunshine Report
hands-on workshop by experts
This sessions will be conducted in both English and Italian
Limited seats available
OCTOBER 14TH, 2024 | MILAN
Hyatt Centric Milan Centrale
OVERVIEW
Join us for a hands-on workshop focused on the Italian Sunshine Report. Our expert-led sessions, guided by seasoned professionals from leading global companies, will provide you with step-by-step practice and training to produce an error-free report, protecting your organization from statutory penalties.
With insights from industry leaders, including experienced professionals from top pharmaceutical companies and legal counsel from a prestigious law firm, you’ll gain the knowledge needed to navigate reporting requirements effectively. Whether you’re new to the process or looking to refine your approach, this workshop will provide the tools and strategies needed to ensure compliance.
KEY BENEFITS
Comprehensive Training: Hands-on guidance to prepare the Italian Sunshine Report accurately.
Expert Discovery Session: One-on-one consultation with industry experts, followed by a detailed discovery report and recommendations.
Networking Opportunities: Engage with industry leaders and peers through discussions and live Q&A sessions.
What You’ll Learn
Italian Sunshine Law: Understand the legal requirements and your responsibilities.
EFPIA & Medtech Benchmarking: Compare the Italian Sunshine Report with existing EFPIA and Medtech standards.
Telematic Register Filing: Learn the process for filing reports in telematic registers.
Case Studies: Review real-world examples to produce error-free reports.
Group Discussion: Participate in discussions on the steps manufacturers should take for compliance.
Who Should Attend
This workshop is designed for compliance professionals, regulatory officers, medical affairs personnel, and others involved in healthcare compliance. It is particularly relevant for those responsible for preparing the Italian Sunshine Report and those seeking to deepen their understanding of compliance best practices and Italian Sunshine Act regulations.
venue
Hyatt Centric Milan Centrale
The event will take place in the Porta Garibaldi
meeting room at the Hyatt Centric Milan Centrale.
REGISTRATION & PAYMENT
1. Fill Out the Registration Form: Complete the necessary details.
2. Receive Invoice: We will send you an invoice.
3. Make Payment: Pay through credit card or bank transfer.
Fee: €850. (This is a non-profit community event, the fee covers only the costs of the venue, session materials, and trainers.)
Discount: A €550 fee is available for a limited number of registrants. This discount is only applicable to employees of life sciences manufacturers.
SPONSORS & PARTNERS
This event is sponsored by Vector Health Compliance.
Vector Health is a leader in compliance services for the life sciences industry, providing a comprehensive solution through the Vector Health HCP Compliance Hub. This hub includes a range of tools such as Engagement, Transparency, Analytics, Monitoring, Speaker Bureau, and more. These are just a few of the features designed to support compliance and legal professionals in managing the full compliance lifecycle. From spend research and transparency reporting to monitoring, analytics, and high-risk spend audits globally, Vector Health offers a robust platform that meets the diverse needs of the industry. With a strong presence across the US, EU, and APAC regions, and 24/7 support, Vector Health is committed to setting the standard for excellence in compliance solutions.
Interested but Have Questions? Join Our free Preparatory Session!
Workshop Preview Series– Part 5
Italian Sunshine Joins the Big Leagues – What to Expect Next?
AT:
10:00 AM – 10:30 AM EST
04:00 PM – 04:30 PM CET
MEET THE INSTRUCTORS | ASK QUESTIONS
This session will be conducted in both Italian and English
Melissa LaFrain
Global Director, Compliance & Transparency,
AstraZeneca
Ned Mumtaz
Former Director, Transparency Operations, Commercial and R&D
Pfizer | Otsuka
Marc Ussini
Commercial Expert Formerly with
JOHNSON & JOHNSON