PharmaLink Conference Sessions Agenda: Day 2

THURSDAY, MARCH 14, 2019

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the country as we kick off PharmaLink Day 2 with a complimentary warm breakfast.


8:30 AM - 8:45 AM

Day 2 Opening

IMG_2802_rev.jpg

Participants will feel the Xavier Difference at PharmaLink, a purpose driven, action-oriented conference. We will start the day recapping the take away points from Day 1 through the Act-Change-Transfer process that will lead to the development of action plans for your key learnings. We insist that our content is meaningful and impactful, so you can’t help but walk away with practical applications to implement when you return to work! 

Speaker:

  • Jim O’Reilly, Professor, University of Cincinnati, College of Law


8:45 AM - 9:30 AM

FDA Provides Insight on the World of FDA Investigators!

The Office of Regulatory Affairs (ORA) manages all the investigators across the country, and is responsible for effectively implementing the inspectional programs at your sites. ORA partners with CDER on inspection and harmonization initiatives, and works with industry and international regulatory partners to ensure safe and effective drugs are available and accessible for the patients you serve. Understand how key ORA initiatives on the horizon, and implementation of Concept of Operations (ConOps), may affect you.

Moderator:

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA (invited)

Speaker:

  • FDA TBAs


9:30 AM - 10:15 AM

MHRA Strategic Priorities and Trends that Impact You Every Day

As the global world becomes even closer and more interconnected, it is imperative that we work together with global agencies to understand emerging complexities of risk to our global supply chains. Global regulators are able to share the trends and rising threats they are seeing across the industry—a perspective that is challenging to observe for any single company on its own. Walk away with a clearer understanding of the strategic and tactical actions MHRA is taking, and actions your company can take today to ensure your product success globally. 

Moderator:

  • Lauryn Congedo, Associate Director, PDQA, Allergan

Speakers:

  • MHRA TBA


10:15 AM - 10:35 AM

Break


10:35 AM - 11:50 AM

TRACK 1 (QUALITY)

Situational Analysis for You to “Navigate the Gray” with Practical Solutions for Real-World Quality Challenges

The complexities of today can be vague and gray, and cannot be solved with yesterday’s solutions. The pharmaceutical professional is often faced with scenarios that have no clear path forward, and must create tomorrow’s solutions with new technology, collaboration and total enterprise perspectives. Participants will gain “real” advice on how to navigate these challenging and prevalent situations with practical solutions that will assure product quality and enable business continuity.

“Supply by Design,” as its name implies, is an intentional development of a product’s supply chain that will perform as intended, and as needed. Participants will be given a practical and intricate map of supplier engagement to ensure material requirements are fit-for-use, the suppliers are engaged at the right time and with purpose, and internal alignment is achieved before engaging suppliers too soon. Learn how to establish your supply chain Right First Time, and hear prevalent examples of how companies fail so you can avoid these missteps.

Moderator:

  • Cathleen Carson, Associate Director, Treyburn & Supplier Quality Assurance, Purdue Pharma

  • Grace Breen, Senior Vice President, SCA Pharmaceuticals

Speakers:  

  • Industry TBA

TRACK 2 (SUPPLY CHAIN)

The 4th Industrial Revolution: Applying New Technologies Today

Some of the most forward-thinking, agile organizations in the world are re-writing all we have known about supply chain operations. Participants will be exposed to some of the latest technological tools that can advance the success of your organization.

Moderator:

  • Ashley Goldberg, Sr. Director, Quality Operations, Merz North America, Inc.

Speakers:  

  • Eric Garvin (Co-Lead of the MediLedger Project), Pharma Solutions Executive, Chronicled

  • Matt Sample, Senior Director, Secure Supply Chain, AmerisourceBergen

  • Susanne Somerville (Co-Lead of the MediLedger Project), Chronicled

TRACK 3 (REGULATORY)

Surprising Reasons for Clinical Holds and Successful Practices to Avoid Them!

According to the Pink Sheet, IND clinical holds by the US FDA have risen 36% since 2014. These holds cause huge concerns for patients for whom an IND offers a glimmer of hope. Companies hoping to speed their drug candidate to market fear the impact that a clinical hold might have on their bottom line. During this interactive session, regulatory experts will discuss common reasons for clinical holds and how to avoid them. Walk away prepared to set your organization up for successful product and approval and launch!

Moderator:

  • Jennifer L. Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer

Speakers:

  • Daniela Drago, Associate Professor and Director, Regulatory Affairs, George Washington University

  • FDA and Industry TBA


11:50 AM - 1:05 PM

Lunch: Drug Reimbursement: Did You Know?

How do insurance companies determine which drugs to reimburse, and how does the FDA risk ranking outcome influence those decisions? The insight gained through this session will empower you to understand how you can affect the outcome for your company and patient success.


1:05 PM - 2:15 PM

TRACK 1 (QUALITY)

Quality Risk Management Across the Product Lifecycle: An Enterprise-Wide Approach                                             

Effective use of Quality Risk Management, as part of the Pharmaceutical Quality Management System enhances the quality and safety of medicines, enables a state of control, and drives continual improvement by incorporating science- and risk-based decisions related to product quality. Industry Experts will engage participants in proven case studies of Quality Risk Management within Supply Chain/Manufacturing, Internal Audit, Post Marketing Surveillance and Supplier Quality Management programs. These successful practices and strategies will enable you to handle risk management across the full product lifecycle in your company.

Moderator:

  • Tami Frederick, Global Director, Corporate Quality Systems and Programs, Perrigo

Speakers:

  • Industry TBA

TRACK 2 (SUPPLY CHAIN)

Is There Power and Potential for Blockchain in the Pharmaceutical Industry?

Could Blockchain and Bitcoin provide the return-on-investment your company is looking for from all the effort and that has been poured into compliance with the Drug Supply Chain Security Act? Having chain of custody established from end-to-end can unlock possibilities for gaining efficiencies, trust, and security while opening new avenues for transactional operations. Learn how to take advantage of the DSCSA groundwork for your company today!

Moderator:

  • David Lowndes, Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations, Shire

Speaker:

  • Matt Sample, Senior Director, Secure Supply Chain, AmerisourceBergen

TRACK 3 (REGULATORY)

Fact of Fiction? Filing Challenges for Emerging Technology

As a Regulatory Affairs professional, you have the ability to pave the way for successful product approval, but can feel thwarted while navigating hurdles related to regulator reviews of new and perhaps unfamiliar technology.  Do you try, or do you avoid innovation?  As the pace of innovation is only increasing, now is the time to decipher what is fact and what is fiction for true regulatory filing challenges.  Learn successful practices you can implement to best support your product filing for the patients you serve.

Moderator:

  • Michael Kaminski, Principal Scientist, Oral Care Regulatory Affairs, P&G

Speakers:

  • Industry TBA


2:15 PM - 2:25 PM

Switch Rooms


2:25 PM - 3:25 PM

TRACK 1 (QUALITY)

External Surveillance Programs to Protect and Promote Patient Health

In today’s reality, we are inundated with a continual stream of information from a myriad of sources that span the globe—varying languages, cultures, credibility, and criticality. The viability of your company’s business is dependent upon your ability to protect and promote patient health. Learn successful practices on how you can bolster your surveillance program to process all available information and remain at-the-ready to take action based on signals you have never had at your fingertips before.

Moderator:

  • Bill Webb, Pharmaceutical and Compliance Consultant

Speakers:

  • FDA and MHRA TBA

  • Brian McCormick, Associate Director, Global Patient Safety, Perrigo

TRACK 2 (SUPPLY CHAIN)

Are Your Drugs Counterfeit? How FDA Can Help You!    

As the complexity of the global pharmaceutical supply chain increases, the threat of criminal tampering and counterfeiting puts your patients and business at risk. The FDA Forensic Chemistry Center will share the latest trends in criminal activity, and the technological advances it is developing to protect patient safety. Learn how industry and FDA can collaborate to combat criminal activity.

Moderator:

  • Steve Eastham, Supervisor, Consumer Safety Officer, FDA (invited)

Speaker:

  • Cheryl Flurer, Supervisory Chemist, FDA (invited)

TRACK 3 (REGULATORY)

Navigating Product Registration in China

China is a key global market for the pharmaceutical industry, but it can be difficult to navigate the review and approval process for a new product registration.  In this session, you will be provided with an overview of the review process, including recent changes, and will have your questions addressed. Walk away with vital information on how to successfully gain approval for your new product in China.

Moderator:

  • Jennifer L. Brown, Director, Global Chemistry, Manufacturing & Controls, Pfizer

Speaker:

  • China National Drug Administration (CNDA, formerly CFDA) (invited)


3:25 PM - 3:45 PM

Break


3:45 PM - 5:00 PM

The Secrets of Successful Meetings with Health Authorities—What You Don’t Know May Hurt You

Imagine if you had a reputation for preparing meetings with health authorities that led to great outcomes. Well-run meetings are effective ways to make decisions, solve problems and build long-term positive relationships with regulators. Mastering the art and science of effective regulatory interactions can make a difference in your job. During this facilitated interactive session, a panel of thought leaders will offer hands-on advice for challenging scenarios requiring meetings with regulators. You will be fully engaged and will walk away with best practices on how to prepare and run successful regulatory meetings.

Moderators:

  • Daniela Drago, Associate Professor and Director, Regulatory Affairs, George Washington University

Speakers: 

  • Davy Chiodin, Vice President Regulatory Science, Quality Assurance, and Compliance at Acerta Pharma (AstraZeneca group)

  • Global regulators and industry TBA


5:00 PM - 7:00 PM

Networking Reception

After the conference sessions on Thursday, benefit from open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with strategic committee members and speakers in a pleasant, informal setting.