03/24

2021

PHARMA SALON Virtual Gatherings Real Solutions

Online

PHARMA SALON

Virtual Gatherings Real Solutions

March Handout

 

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

0837-9999-21-004-H04-P

  • 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

0837-9999-21-005-H04-P

  • 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

0837-9999-21-006-H07-P

  • 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

0837-9999-21-007-H04-P

  • 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

0837-9999-21-008-H04-P

  • 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

0837-9999-21-009-H01-P

  • 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

0837-9999-21-010-H07-P

  • 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

0837-9999-21-011-H04-P

  • 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

0837-9999-21-012-H07-P

  • 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

0837-9999-21-013-H07-P

  • 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

0837-9999-21-014-H03-P

  • 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

0837-9999-21-024-H07-P

  • 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

0837-9999-21-025-H07-P

  • 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

This website uses cookies to understand how you use the website and to improve your experience. By continuing to use the website, you accept the University of New England’s use of cookies and similar technologies. To learn more about our use of cookies and how to manage your browser cookie settings, please review our Privacy Notice.