Pre-Meeting Hot Topic Breakfast Roundtables

Roundtable 1: Speeding Innovation Through Global Regulatory Convergence

Moderator: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
Presenter: Glenn E. Wright, MA, President and CEO, PDA

Industry is often asked the ever-important question, "What regulatory changes would help companies speed drug products to the patients that need them and actively prevent drug shortages?"

As the current process requires multiple, repetitive reviews between regulatory authorities (regional or local), significant delays often slow the introduction of novel, lifesaving products and the implementation of manufacturing innovation. Is there a better way to accomplish the scientific review required for new product applications and post-approval changes?

Roundtable Focus

Let's think about starting with a clean sheet of paper. If you had the power to establish a global convergent regulatory process for new product applications and post approval changes, what would it look like? The session will kick off with a short 15-20 min presentation on several initial high level strawman models and the roundtable will take it from there.  Bring your ideas and creativity!

Who Should Attend

Individuals with knowledge and expertise in regulatory affairs that are interested in:

• Global new product application approval processes
• Global post approval change processes
• The concept of regulatory convergence as a tool to reduce approval times while still ensuring the appropriate level of scientific review

Roundtable 2: Training of the Future

Moderator: Kate Malachowski, PhD, Associate Director, MS&T, Novavax

The world continues to change with the implementation of greater digitalization and automation, as well as a changing workforce with differing learning styles. With all these changes, what will the training of the future look like? This roundtable will explore these questions and will attempt to answer this very elusive question.

Roundtable Focus

• The challenges industry is facing in training
• Shifts in the learning style we are seeing as new generations of employees enter the workforce
• The role technology plays in shaping the future of training

The roundtable will start with a short 15-20 min presentation to set the stage for the roundtable discussion. Bring your knowledge, experience, and creativity to this roundtable as we buckle up for a great discussion and try to sort it all out.

Who Should Attend

Individuals with experience in industry training that are interested in:

• Discussing the training challenges facing the industry today
• Sharing (benchmarking) observed trends in training
• Discussing how technology may be used in the future
• Creating a high-level view of what training of the future could look like

Roundtable 3: 503B Compounding Facilities

Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

It has been just over 10 years since legislation went into effect that provided the U.S. FDA more oversight responsibility for 503B compounding facilities. Much has changed within this part of the industry, from evolving business models to new guidance and evolving expectations.

Roundtable Focus

This roundtable will focus on the challenges 503B compounders are facing today. It is a chance to come together, have open discussions, and learn from one another. The roundtable will start with a 15-20 min presentation on how the industry in this area is evolving to set the stage for the roundtable discussion.

Who Should Attend

Individuals involved in the compounding industry that are interested in:

• Discussing the continuing evolution from a compliance and operational standpoint
• Sharing emerging trends and concerns
• Benchmarking on topics of interest

Roundtable 4: Early and Mid-Career Professional Development

Moderator: Divyang Patel, Senior Specialist, Commissioning, Qualification & Validation (CQV), AtkinsRealis
Presenter: Ira Mann, President and Head of Referrals, IQ Referrals

Question: When should early career and mid-career professionals start thinking about their career and the steps they can take to enable and prepare for future opportunities?

Answer: Now, and always!

As the saying goes, if you don’t know where you’re going, don’t be surprised if you get lost. Careers can take different paths, some in the way you desire and some in unexpected ways. Preparing early is the best approach and, while it is never too late to act, it is best to begin preparing early in one’s career.

Roundtable Focus

• Actions you can take to advance your career and actions
• Common mistakes to avoid
• Actions you can take to understand what targets make sense for you
• Steps you can take to start preparing for advancing your career
• An opportunity to have your own questions answered, to learn from one another’s questions and experiences

The roundtable will be led by Ira Mann, President of IQ Referrals.  Ira has been helping industry members find their passions and advance their careers for over 20 years. Starting out climbing the ranks in compliance and auditing and pivoting to a career of creating impactful career matches for others while building long-term relationships with influential industry leaders, Ira has unique insights into our industry and significant success in preparing individuals and companies for their future. The roundtable will start with a short presentation to set the stage for the roundtable discussion and the opportunity for you ask questions – so you are welcome come prepared to not only ask questions but also get involved in the discussion. 

Who Should Attend:

Early and Mid-Career Professionals who:

• Want to prepare to advance and empower your career
• Have questions on how to effectively advance your career
• Wonder how to address career advancement obstacles you’ve encountered
• Want to learn about important attributes and experiences sought in today’s world
• Want to know how to stand out from the crowd
• Want insight into what’s important to know about yourself