Tuesday, May 17
Are you up-to-date on all the recent state law changes? State laws seem to be changing on a weekly basis and they are very challenging to keep up with. This workshop will assist you in remaining compliant with all of the recent state law changes.
The focus of this workshop will be on these state-specific requirements, such as:
- Recent changes/updates to State laws
- State sample theft and loss reporting requirements
- State sample transparency reporting
- Unique state licensing considerations, such as the different expiration models and use of grace periods particularly in light of COVID-19, and how they can impact sample distribution practices
- Ohio Terminal Distributor of Dangerous Drugs licensing and impact on sample distribution and practitioner validation
- Oregon sales representative licensure law
- State privacy laws
Pharmaceutical companies rely heavily on 3rd party vendors to keep their business moving forward. As demonstrated during these pandemic times, a trusted partner is an extension of your organization. For successful business operations, vendors need to do more than provide service, but rather, they need to be agile and provide solutions. We will touch upon the following merits of a successful relationship in our presentation: Strategic Alignment, Communication, Data Sharing, Compliant Solutions, and successful Program Monitoring.
Life science companies face increasing scrutiny from federal and state regulatory agencies concerning business practices, such as those associated with marketing and quality-related issues. The Food and Drug Administration, the Justice Department, the Office of the Inspector General of the Department of Health and Human Services, and state authorities continue to investigate pharmaceutical and medical device companies for compliance with applicable laws. Failure to comply can have serious negative consequences, whether non-approval of a product, a Warning Letter, issuance of import alerts, court action, or the imposition of hefty fines, to name only a few. In this informative session, we will review types of non-compliance issues that could raise litigation risk. We will discuss typical litigation-type consequences for non-compliance and recommendations to minimize such risk.
The complexities around license data validation can certainly feel overwhelming. However, our two well-prepared presenters are ready to explain why it does not have to be that way!
This workshop will offer a look at the value of investing in a defined license validation process for
your organization to maintain compliance with regulations and internal requirements.
This open discussion will focus on:
- Overview of License Types Understanding License Compliance Use Cases–Federal and State Defining
- Your Validation Standards Acceptance Criteria and Managing Exceptions Vendor Engagement for License
- Data Acquisition Documenting Processes Educating Stakeholders
- Leveraging Validated License Data for your Business Needs
And, of course, there will be time allotted for the sharing of best practices and Q&A conversation.
This breakout session focuses on critical components to the success of the workplace in a post pandemic world. Isolation, work from home, virtual meetings, and a myriad of other factors have forever re-shaped and re-prioritized the best practices of creating a peak performance environment. Attendees will learn about the importance of informal communication in a virtual work environment, how to better resolve conflict with fewer face to face interactions, and how to recognize, respond, and mitigate the influence of stress in the workplace of the future.
Wednesday, May 18
Conducting for-cause audits is a requirement of the FDA’s Prescription Drug Marketing Act (PDMA) and is critical to ensuring a compliant Sample Accountability program. For-Cause audits are a key component of a manufacturer or authorized distributors’ sample distribution security and audit system. What is a “For-Cause” audit? Does your Compliance Program include these audits? Can you strengthen your existing program? How can you conduct effective and efficient for-cause audits? In this workshop, you will find the answers to those questions and more. Attendees will learn what information should be included in for-cause audits and hear recommended approaches and techniques for conducting for-cause audits which will enhance your overall regulatory compliance efforts. This workshop will also focus on the importance of trending sampling activity and how to identify the triggers that indicate the need to conduct a for-cause audit. It will also provide Attendees an opportunity to share various experiences and lessons learned in conducting these audits. Implications of conducting effective for-cause audits during the pandemic will also be addressed.
Maybe the acronym “ARCOS” is part of your workday language. Perhaps it’s just one of those things you have heard in passing and thought you should know more about. Whatever your level of ARCOS knowledge may be, our two experienced presenters are well-versed in DEA knowledge and well-equipped to discuss how to best utilize ARCOS data to help minimize risk to companies.
The DEA’s Automation of Reports and Consolidated Order System (ARCOS) is an automated, comprehensive drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level – hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions. The DEA requires that manufacturers and distributors review ARCOS retail buyer statistics before shipping any controlled substance.
This workshop will highlight some critical techniques to help you best understand and utilize ARCOS data to reduce your company’s risk. Whether you need to have this information now, or you want to be ready just in case, you’ll be glad you attended this very informative learning session.
Identified as one of the key risk areas that manufacturers need to address in the coming year, drug price transparency reporting laws have been enacted exponentially over the last few years.
The number of states effected has grown to where almost half of the US requires manufacturers to report drug pricing, with each state having different requirements or reporting triggers. When establishing a process for reporting, manufacturers have to include multiple factors to consider when determining the reporting required in each state.
Is your head spinning yet?
This jam-packed workshop will provide a high-level overview of the many facets in the reporting requirements, triggers for reporting, and the significant fines for non-compliance in each state. So whether you’re simply interested in learning more about this critical area in the business or you’re tasked with challenging transparency reporting responsibilities, this workshop will be an educational resource for all.
We all agree it’s important for pharmaceutical compliance professionals to stay current on existing
guidance and best practices for mitigating risks, right?
So it should be no surprise to anyone that those risks are amplified when engaging in social media.
In recent years, using social media has become a very common method for individuals, institutions,
and governments for communication and collaboration. Companies must be aware of the legal
expectations and responsibilities for monitoring interactive comments which may contain product
safety reports, complaints, off-label use, patient privacy, or misinformation.
With the variety of social media channels available for companies and individuals/employees today,
it’s critical to have guidance in place to avoid problems. Our workshop presenters will review and
offer their insights on the benefits, risks, and responsibilities for organizations when utilizing social media platforms. Q&A will follow their impactful presentation.
Sample Distribution Models have been evolving over the past 15 years. However, the most significant changes have occurred in the past few years. These changes have been implemented to maintain operational efficiency and regulatory compliance. Key causative factors for these changes include reduction in field sales representatives; increase in cold chain products for sampling; the COVID-19 pandemic and subsequent FDA guidance; and, highly restrictive access/no access to practitioners.
This panel discussion will cover existing models, shifts within the sample distribution umbrella, new models, and hybrid models bridging pieces from existing sample distribution models. The presentation will include:
• An overview of the aforementioned models
• The benefits associated with each model
• Unique compliance issues associated with migrating to a different model and how best to mitigate the risk
• Operational efficiencies gleaned and/or additional expenses incurred
• Monitoring and trending of the data to self identify areas of risk, with a corrective action plan
• Looking into the crystal ball – what does the future look like
Since 2019 there has been a supply chain shortage that has effected the nation. One area that is becoming painful for companies is fleet programs. During this session learn about the pros & cons of car allowances vs. fleet vehicles.
The workshop speakers will round out the recent Sharing Alliance workshops and white papers on data governance and its framework and put it into business perspectives.
Prior details have been provided on what is a data governance framework and its focus on data quality. Much technical focus on the what and how, this session will focus on the why.
The workshop will expand on that journey to success but why all this fuss on data quality. It will provide the business side dynamics on why pharma focuses on data quality. The speakers will provide organizational reasons and examples on why its integral to the organization’s success. Whether during startup, uphill trajectory or maturity. More importantly, look at Marketing, Sales and Compliance aspects to illustrate that all verticals within the organization need to focus on data quality and a single source of truth in order to be successful.
Thursday, May 19
The focus of this workshop will be to provide an overview of OIG’s recently issued Special Fraud Alert associated with Speaker Programs. It will highlight the rationale behind this alert, talk about certain risk characteristics of Speaker Programs, and key considerations for pharma and device manufacturers to execute these programs with a reduced risk profile. In addition, we will talk to how pharma and device manufacturers can effectively monitor and oversee these activities that can help enhance compliance program effectiveness.
Counterfeit medicines and vaccines have always been a threat to public health.
Concerns with counterfeit and diverted drugs led to the enactment of the Prescription Drug Marketing Act of 1987.
Throughout the pandemic, we have seen a global surge in black market sales. Pharmacists, patient advocates, regulators, law enforcement, pharmaceutical companies, and wholesalers share concerns about the threat counterfeit drugs pose to American patients.
Attendees will be riveted hearing from this industry expert uniquely positioned to educate on the scope of, and risk posed by, the ever-evolving likelihood and dangers of fake medicines.
In addition to a very full agenda of workshops and general sessions, we will also be offering more Open Forum time than ever before, focused on a wide variety of topics. Is there a particular subject you’d like to have discussed during one of the Open Forums? Send your suggestions here – we welcome your input!