Written by NoriYah Yisrael, MS-PM, PMP, CPPM, FAAPM

Presentation Overview

On August 11, 2022, the Clinical Research (CR) Forum of the PMI Atlanta Chapter hosted the "Tips on Study Start up, Clinical Trial Conduct and Preparing for an FDA Inspection" Special Interest Forum Event as presented by Professor Toks Onabanjo. The purpose of this event was to provide an overview of how to prepare for study start-up, patient data collection, and an FDA inspection and approval to market a new drug in the United States (US).

During this forum, Professor Onabanjo discussed the requisite skills that make for a successful Project Manager within the CR industry. He spoke about the site selection process that begins with the site completing a feasibility questionnaire which includes questions pertaining to the site’s personnel qualifications, capabilities, and patient population.

Once the sponsor and investigative site make a mutual decision for the site to participate in the study, the study start-up process commences. During this phase, sites must submit documentation to the sponsor, as required by governing entities and organizations to include regulatory agencies and institutional review boards. After everything is submitted and approved, the sponsor may conduct an Investigator Meeting and/or a site initiation visit, which are training pre-requisites that must be fulfilled before the site can begin consenting and enrolling patients in the study.

After a study is conducted, the sponsor may analyze and submit the patient study data that it collects from the sites to the Food and Drug Administration (FDA) in a New Drug Application. The FDA then reviews the application and could potentially inspect one or more investigative sites prior to making a formal decision on whether to approve the drug for marketing in the US.

Takeaways

• The sponsor and the investigative site must mutually decide on whether a study is feasible and beneficial for the site to be selected to participate.
• Study Start-Up is a complex process that takes the coordinated efforts of both the sponsor and the site to complete.
• The data collected on participating patients at the investigative sites are analyzed and, if appropriate, packaged for submission to the FDA for US market approval.

Next Event

Join us at the next PMI Atlanta Clinical Research forum on Thursday, November 10, 2022.

Register at www.pmiatlanta.org/events/event-calendar

Written by: Rishea Middlebrooks CAPM, ACHE Student Associate

Meetings, escalations, and pandemic concerns, oh my! We often find ourselves with limited time, mounting priorities, and looming deadlines. Find out how utilizing key project management skills are essential to keep composure, instill confidence, and build trust.

Presentation Overview 

James Brooks explained the critical project management skills needed to navigate the fast-paced world of healthcare. This included a review of the dynamics of the healthcare continuum and the required preparation to navigate it successfully so anyone can map the process for themselves. 

Takeaways

• People first
  • Get buy-in early and often
  • Start with motivating and inspiring the team
  • Lean on each other (e.g., accountability culture)
  • Win hearts and minds through action
  • Identify team strengths and let them FLOURISH
  • Deliver meaningful feedback
• Customers for life
  • Embrace your role as customer advocate
  • Always keep your promises and follow-up
  • Listen with intent and act when appropriate
  • Understand ways of communicating
  • Ask tough questions
• It's all in the details
  • Understand your core processes
  • Challenge the “norm”
  • Inspect what you expect
  • Limit the noise
  • Don’t overthink it!
• Checks and balances
  • Understand your boundaries
  • Stay within your “lanes”
  • Keep it simple!
• Show me the money!
  • Keep your financial commitments
  • Don’t be afraid to take risks
  • Build the value proposition
  • Plan for the future … play the long game!
  • Build brick by brick

Next Event

Join us at the next PMI Atlanta Healthcare Forum on October 19, 2022

Register at www.pmiatlanta.org/events/event-calendar

Event Pictures

Written by Rishea Middlebrooks, CAPM, ACHE Student Associate

From the wise words of Marissa Mayer “I have a theory that burnout is about resentment. And you beat it by knowing what it is you’re giving up that makes you resentful.” Today, take some time to self-assess your level of burnout and discover tools and techniques to identify and eliminate areas of burnout and resentment in your life!

Presentation Overview

With the appropriate tools, we each have the power to minimize the negative effects of stress and increase personal well-being in the workplace. D’Yonna Riley, Associate Certified Coach at Nirvita Health, reviewed the impact of burnout in the workplace, as well as effective strategies to beat burnout and continue to be a high performer. She also covered how today’s leaders can create a team culture that promotes well-being and reduces burnout.

Takeaways

• The Future of Burnout

  • Virtual fatigue is on the rise
  • More video calls
  • More hours spent working
  • No separation from work and home

• The effects of burnout

  • Job dissatisfaction
  • Physiological issues
  • Withdrawal & isolation
  • Likelihood of substance abuse

• Types of workplace burnout

  • Deadline burnout
  • Culture burnout
  • Personal burnout
  • Skill burnout
  • Alignment burnout
  • Passion burnout

• Burnout Strategies

  • Mindset – recognize, feel, replace
  • Prioritization – implement laser-focused prioritization
  • Boundaries – give yourself space to reset daily
  • Movement – move your body in ways that nourish you
  • Nutrition – control the stress response through appropriate food
  • Connection – surround yourself with supportive people and nature

Event Pictures

Written by: Catherine Binuya, Ed.D.

Presentation Overview 

Elba Pareja-Gallagher is the UPS Sustainability Director (https://about.ups.com/us/en/social-impact/environment/sustainable-services/sustainability-trailblazer-elba-pareja.html) and ShowMe50 Founder (https://www.showme50.org/author/elba/). She presented on the origins of the sustainability movement and the current implications of ESG (E—Environmental Care, S—Social Responsibility, G—Government Ethics), and why it is important in global politics and business.

Takeaways

• The background of sustainability—
  • Sustainability spurs innovation. Industries must be able to adapt and adopt ESG to save costs, and create opportunities, and thrive and grow.
• SEC (U.S. Securities and Exchange Commission) in the news—
  • The SEC ruled, in March 2022, to require publicly traded companies to report on extensive climate related information and climate risks, via financial statements, e.g., Green House Gas (GHG) emissions, financial implications, Carbon Footprint. Set goal for US industries to be Carbon Zero by 2050.
• Time travel—why ESG?—
  • The ESG movement is rooted in pivotal events across each decade beginning with the Vietnam War giving rise to social-political activism in the 1970’s; to the focus of socially responsible investing in the 1990’s-2000’s; to global-political initiatives such as the Paris Agreement, UN Sustainability Goals, impact of COVID-19 and Black Lives Matter (BLM) in 2010’s-2020’s.
• Drill down of ESG—
  • Environmental Care includes considerations for: air pollution, water pollution, carbon emissions, energy efficiencies, waste reduction, water conservation, biodiversity. Fact: processing concrete accounts for 8% of global emissions.
  • Social Responsibility includes considerations for: equity, diversity, labor standards, customer protections, production responsibilities, human rights, human capital.
  • Government Ethics includes considerations for: board diversity, executive pay, audit structures, shareholder democracy, ethics and compliance, anti-corruption, lobbying, IT security and cyber risks.
• Diagram of the balance and intersection of E, S, G—
  • Successful sustainability is achieved by balancing the needs of stakeholders at the intersection of all three E, S, and G (e.g., venn diagram model).
  • The UN (United Nations) defines sustainability as: meeting the needs of the present without compromising future generation’s ability to meet their own needs.

Additional Recommended Resources:

• • • Podcasts: MSCI ESG Now, SNP Global ESG Insider, Green Biz
    • Books: “How to avoid a climate disaster: The solutions we have and the breakthroughs we need” by Bill Gates, “Climate Change and the Road to Net-Zero” by Dr. Matthew Hampshire-Waugh

Next Event

Join us at the next PMI Atlanta AEC forum (TBD)

Register at www.pmiatlanta.org/events/event-calendar

Event Pictures