PHARMA SALON Virtual Gatherings Real Solutions



Virtual Gatherings Real Solutions

March Handout


Building Business Relationships for success in the Good Times and the Bad


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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

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