Main Conference Sessions Agenda: Day 1

WEDNESDAY, MARCH 18, 2020

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues from around the country as we kick off PharmaLink 2019 with a complimentary warm breakfast.


8:30 AM - 9:00 AM

Let’s Make a Difference!

Welcome to the conference, welcome to Xavier University, welcome to FDA Pharma Division III, and welcome to the FDA Cincinnati District. This purpose-driven conference will lead you to actionable learning and implementation plans.

Moderator: 

  • Marla Phillips (Co-Chair), Director, Xavier Health, Xavier University

Speakers:

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

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

  • Marla Phillips (Co-Chair), Director, Xavier Health, Xavier University


9:00 AM - 9:45 AM

The Solution Xchange

As my first experience with a conference I am finding it to be an excellent learning opportunity. There is a great mix of topics and ability to interact with a diverse group of people.
— PharmaLink 2019 Attendee

Start your day with solutions! This fast paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues. Address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.

Facilitators:

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

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

  • Regina Shipman, Global Section Head, Health Care Quality Systems & Capabilities for Cosmetics, Devices, Drugs & Food, Procter & Gamble


9:45 AM - 10:05 AM

Break


10:05 AM - 10:50 AM

A Healthy World

We will explore how global health organizations are working to eradicate inequity in healthcare, and how together we can save lives by delivering the latest in science and technology to those in need.

Moderator: 

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

Speakers:

  • TBD


10:50 AM - 11:35 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 key ORA initiatives underway and that are on the horizon.

Moderator:

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

Speakers:

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA (invited)

  • Ellen Morrison, Assistant Commissioner for for Medical Products and Tobacco Operations, FDA-ORA (invited)


11:35 AM - 12:20 PM

ANVISA – Initiatives and Trends

The Brazilian Health Regulatory Authority will share its perspective on trends in new product applications, inspectional challenges emerging technology.

Moderator:

  • Leslie Weiss, Director, Global CMC Regulatory Affairs, Janssen Research & Development

Speakers:

  • ANVISA (confirmed) Speaker TBD


12:20 PM - 1:30 PM

Lunch Networking by Topic

Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion on these topics:

  • How to Measure CAPA Effectiveness

  • CMC Filing Challenges in Emerging Markets

  • Learnings from Global Inspections


1:30 pM - 2:15 PM — Tracks

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Predictive Capabilities Track

In a world of innovative processes, products, and business partnerships, explore successful practices to increase the trust your patients have in you.

Moderator: Tami Frederick Global Director, Corporate Quality Systems and Programs, Perrigo

1:30 PM - 2:15 PM

First Steps First: Exploring the Identification of True Root Cause through Complex Failures, and How to Measure CAPA Effectiveness

Speaker: Christine Teipen Smith, Director of Global Quality Systems, Eli Lilly

Global Regulatory Strategies Track

Advancing Regulatory Strategies to support the speed of innovation and the needs of your global patients

Moderator: Leslie Weiss, Director, Global CMC Regulatory Affairs, Janssen Research & Development

1:30 PM - 2:15 PM

Part 1: Emerging Market CMC Filing Challenges: Lessons Learned from Industry across LatAm, APAC, and AfME

Speakers: ANVISA (confirmed); Jen Brown, Director Chemistry, Manufacturing & Controls, Pfizer; Industry Speaker TBD


2:15 pm - 2:35 PM

Relocation Break


Predictive Capabilities Track
2:35pm - 3:20pm

Integrated Risk Assessment and Business Intelligence to Improve Culture and Predictive Capabilities

Speakers: Thomas Friedli, Professor for Production Management at St. Gallen University in Switzerland (FDA Collaboration on Quality Metrics); FDA Speaker Confirmed TBA

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Global Regulatory Strategies Track
2:35pm - 3:20pm

Part 2: What You Need to Know: Global Summary Documents (CPID, Korea, J-AF, Russia ND, Brazil PATE) and ICH Guidance Updates

Speakers: ANVISA (confirmed); Jen Brown, Director Chemistry, Manufacturing & Controls, Pfizer; Industry Speaker TBD


3:20 pm - 3:40 pm

Relocation Break


3:40 PM - 5:00 PM

Chief Quality Officers Mobilizing Enterprise-wide Effectiveness

In this hands-on session, hear directly how Chief Quality Officers are working collaboratively across the industry to create the future-state role of Quality, while preparing the next generation of scientists coming behind us. Provide your input to help shape the future direction of this industry-shifting work!

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers:

  • Anthony Mire-Sluis, Head of Global Quality, AstraZeneca

  • Laura O’Brien, SVP Global Quality, CSL Behring

  • Peter Shearstone, Vice President, Global Quality Assurance and Regulatory Affairs, Thermo Fisher Scientific


Cincinnati Museum Center

5:45 PM - 8:30 PM

Annual PharmaLink Dinner at Cincinnati Museum Center

Cincinnati Museum Center is a one-of-a-kind, multi-museum complex housed in Union Terminal, a historic Art Deco train station and National Historic Landmark. Museum Center's major offerings at Union Terminal include the Cincinnati History Museum, the Cincinnati History Library and Archives, the Duke Energy Children's Museum, the Museum of Natural History & Science and the Robert D. Lindner Family OMNIMAX® Theater. Museum Center is the largest cultural institution in the city of Cincinnati, with more than 1.4 million visitors per year and its collection encompass more than 1.8 million artifacts, art works, and archives. The evening will be capped with a dinner.