PHARMA SALON Virtual Gatherings Real Solutions
PHARMA SALON
Virtual Gatherings Real Solutions
March Handout
Building Business Relationships for success in the Good Times and the Bad
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- Understand how new technology systems impeded building relationships and how to get back to a personalized sales cycle
- Review the benefits of personal relationships especially in a pandemic and post pandemic world
- Prepare to go back to basics; mailing, faxing, emailing and welcome kits
How Knowing Your Customer Contributes to Finding and Filling Voids that Lead to Business Growth
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- Outline how successful marketing includes a deep understanding of your client’s business
- Review programs put n place by StanleyRX that demonstrated a need and understanding of client’s business
- Summarize business opportunities with the client based on your observations and conversations
- Review programs for your client that demonstrate your knowledge of their challenges and how your solutions solve those problems
2021 Compounding Policy and Oversight Update
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- Identifying and describing recent FDA policy developments of drug compounding
- Recognize FDA oversight approaches during COVID-19
- Review upcoming offerings from FDAs Compounding Quality Center of Excellence
How to Address Concerns Raised by FDA with a Limited Budget
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- Explain how to be proactive-develop plans, policies, and procedures, and prepare for interactions with FDA
- Recall: document, document, document-Specifically during the COVID-19 Public Health Emergency, FDA is changing policy weekly if not daily
- Review the guidance-FDA guidance is not binding buy represents the current thinking of the agency
How to Carry Out FDA Recommended Automation on a Budget
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- Discuss the importance of working with the CFO to establish How to Carry Out FDA Automation on a Budget minimum ROI
- Classify vendors as partners and work with them on options, full automation, semi-automated or digital assistant
- Review implementation strategies and required in-house and by manufacturer validation as well as SOPs and training
Pandemic SOPs: Today and the Future
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- Identify COVID-19 Pharmacy’s Toolbox
- Describe the evolving issues and concerns facing pharmacy and pharmacists during the pandemic
- Recognize how to keep your community pharmacy running during the rapidly changing COVID-19 pandemic to ensure patient safety
Role of Compounding Pharmacy in the Future of Clinical Management of Diseases
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- Recognize that as we redefine the way clinical management of diseases are done, the role compounding pharmacies could play
- Explain how compounding pharmacy can deliver novel medicines including combinations, with the ability to fine tune the dose to a specific patient
- Summarize the technical, regulatory, and logistical challenges compounding pharmacies need to consider
Compliance, Fraud and Your Outsourced Sales Team
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- Review why pharmacies hire outside sales teams, pros and cons
- Express understanding of promotional compliance and the risks involved to your sales team
- Identify SOPs to ensure compliance of your 3rd party vendor
Expand of Your Business through Investigative Drug Development
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- Outline the situation of investigational drug clinical research sites that don’t have adequate in-house compounding capabilities and the need for partnerships with local compounding pharmacies
- Explain the regulatory environment for developing investigational drugs
- Review the costs, procedures involved with the opportunity to make more money and also be an active actor in the process of bringing medicines faster to the public
- Indicate ways to approach pharmaceutical companies and investigational drug clinical research sites who may be looking for compounding pharmacy partnerships
Moving from 503A to a 503B Pharmacy
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- Review facility design changes you will need to consider
- Discuss the need to move to a GMP mindset
- Review from people who have done this, what they knew before starting the process
Collaborative Practice and Other Arrangements between Prescribers and Pharmacists-A California Model for Opportunities to Render Clinical Care in Community Pharmacies
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- Explain California laws and regulations that allow for pharmacists to expand their scope of practice in community pharmacy settings
- Discuss common myths and pitfalls of collaborative practice agreements and other protocol agreements between prescribers and pharmacists
- Recognize the necessary elements of a collaborative practice agreement to effectuate the clinical objectives of that collaboration
Production Scale and Efficiency
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- Review methods to assess Current Capabilities
- Recognize how to determine Barriers to Scale
- Explain ways to develop a Production URS
- Identify how to improve systems for implementation and validation
The 503B Landscape-Lessons Learned from FDA oversight
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- Describe briefly the genesis of the Outsourcing marketplace along with it’s scope and overlapping regulatory authorities who could enforce standards
- Discuss the current regulatory environment with focus on the most common citations confronting Outsourcing Compounders
- Identify the key safety issues surrounding the use of an outsourcing compounder and how to analyze and vet their processes for delivering compounded sterile & non-sterile preparations to your hospital, health system or practice