Life Science Compliance Update

May 15, 2015

Biosimilars 20/20 Conference: June 3-4 in Philadelphia, PA

Specialty

Biosimilars 20/20 will take place from June 3 – 4 in Philadelphia, PA. The two-day conference is presented by the Specialty Pharma Education Center (SPEC) in partnership with the Specialty Pharma Journal (SPJ), and will offer a host of important presentations on a timely subject. Tom Sullivan, Editor of Policy and Medicine will moderate the panel “Regulatory and Legal Challenges in Commercializing Biosimilars in the US.”

With FDA’s approval of the first biosimilar product in March, 2015 promises to be an important year for what will soon become a large and dynamic industry. Biosimilars 20/20 brings a wide range of impressive speakers and diverse perspectives together to provide the full picture of where we are now and what the future holds for biosimilars in the US.

  • Biosimilars Pipeline Update: A Look Into The Future
  • Regulatory and Legal Challenges in Commercializing Biosimilars in the US
  • Challenges Related to Interchangeability of Biosimilars
  • Challenges Hindering Advancement & Approvals of Biosimilars in the United States
  • Research & Development: Scientific Challenges in Biosimilars
  • Biosimilars in the Market: A discussion on the Evolving Market Response from Innovator Biologic Manufacturers
  • Improving Patient Outcomes: Perspectives from Physicians and the Value of Patient Education
  • Payer Perspectives: Insights on Biosimilars

The conference also features a case study on Oncobiologics, a biopharmaceutical firm established in 2011, focused on the development, manufacture and commercialization of high-value complex biosimilars. The company’s current pipeline represents more than $100 billion in global revenue at time of patent expiry. Hear the inside story of this firm’s remarkable evolution directly from its CEO.


“With new developments involving regulations, drug approvals, and delivery-system innovations, biosimilars are paving the way for more individualized treatment options for patients around the world. With the recent emphasis in the United States on precision medicine, it is imperative to understand all aspects of this emerging sector.”

                        -Biosimilars 20/20, Register Here

Policy and Medicine readers receive a $400 discount from the registration price.

Just use the code: BIOSIMSRP400

 

May 13, 2015

ExL Pharma 6th Aggregate Spend and Sunshine Act Conference

Agg Spend and Sunshine Conference

ExL Pharma's 6th Aggregate Spend and Sunshine Act Conference will take place on June 8-9 in Philadelphia, PA. The conference has an impressive array of speakers and presentations that promise to offer important insight into Open Payments requirements and shed light on best practices based on two years of reporting. The core areas to be addressed during the conference are: disclosure issues, dispute resolution methodologies, reporting protocols, transparency enhancements, and submission techniques. 

The press release states:

With our 6th Aggregate Spend and Sunshine Act Conference, our expert speaker faculty discusses what can be learned from the first full reporting cycle. Find out how to improve your processes and systems, tackle and resolve disputes quickly, and ensure data consistency. Experts from pharmaceutical, biotechnical, healthcare and medical device companies can learn from and benchmark against each other to identify if they meet the industry status quo and become better in all stages of the aggregate spend journey.

The two-day agenda has a comprehensive list of important programs that should resonate with a wide-variety of life science stakeholders, including the following:

  • Case Study on Protocol Enhancements in Sunshine Act Filing for the Evolving Industry
  • Adapt Aggregate Spend Process Improvement in the Transparency Reporting Realm
  • Preparation for Potential Mergers and Acquisition Reporting with CMS
  • Generate Solutions to Limit Operational Hindrances in Dispute Resolutions
  • The Impact of Disclosure Regulations on Clinical Research
  • Implement Strategies for Data Review and Remediation
  • Explore Discrepancies and Challenges Due to the Recently Completed March Data Submission
  • A panel discussion, entitled: Optimize Transparency Reporting Protocols with Distribution, Grant Approval and Global Business Policies
  • Resolve Issues Surrounding Assumption Documents to Avoid Discrepancy
  • A panel discussion, entitled: Apply Enhanced Methodologies to Internally Align Complex State Transparency Requirements
  • Improve Reporting Compliance Through Fundamental Modification and Specific Attention to Requirements

The full conference agenda, including speakers is available here

Register for the 6th Aggregate Spend and Sunshine Act here

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