2019 ISPE Global Pharmaceutical Regulatory Summit
5 – 6 Dec 2019

Thank You for Making this Conference a Huge Success!


The 2019 ISPE Global Pharmaceutical Regulatory Summit kicked off with David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), #HRA, touching on how big data approaches will transform how the #pharma industry and regulators operate.


What regulatory efforts are being made towards standardizing technologies?

Sau Lee, PhD, Director & Emerging Technology Team Chair, Office of Testing & Research, OPQ/CDER/FDA, and Manuel Osorio, PhD, Senior Scientist for Emerging Technologies & Medical Countermeasures, CBER CATT/FDA, offer their insights per their respective FDA center-level organizations.


Ingrid Markovic, PhD, Senior Director, US Pharma Technical Regulatory, Genentech, challenges attendees to change the way they think about their role and keep patients top of mind during her presentation “Accelerating Development of Innovative Therapies: A CMC Perspective.”

Ingrid Markovic, PhD


The 2019 ISPE Global Pharmaceutical Regulatory Summit concluded with the Global Reliance and Harmonization Panel Discussion, which brought together pharma professionals and regulators from around the world. In our regulatory world of pharmaceutical manufacturing, we encounter 48 different pharmacopoeias and 20 different sets of GMP globally basically regulating the same work. Harmonization or reliance has long been the holy grail but progress has been at a glacial pace. In this session attendees learned about areas where reliance has yielded results, and an area where progress has not been as rapid.

Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA joined the panel, along with:

  • David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation (Expert GMP Inspector), MHRA
  • Tara Gooen Bizjak , CDR, Senior Science Policy Advisor, OPQ, FDA
  • Jaap Venema, PhD, Executive Vice President & Chief Science Officer, United States Pharmacopeia

Session lead by Søren Thuesen Pedersen, Senior Director, External Affairs, Quality Intelligence and Inspection Novo Nordisk A/S

Alonza Cruse, David Churchward, Tara Gooen Bizjak, Jaap Venema, PhD


What learnings can we gain from accelerated approvals that we can apply to regular developments?

Mahesh Ramanadham, PharmD./M.B.A., R.P, Senior Scientific and Policy Advisor (Acting), Office of Process and Facilities, FDA/CDER/OPQ, shares his thoughts during the Accelerated Development session.


Hear from Alex Viehmann, Operations Research Analyst, FDA/CDER/OPQ/OS, as he discusses discerning practical differences in your Quality Maturity Rating program.


Be bold, don't be afraid of anything. Take any challenge on but stay authentic. Know yourself very well and what your limitations are, but still be uncomfortable and be an advocate for yourself.

Vivianne Arencibia, Independent Consultant, Arencibia Quality Compliance Associates during the Women in Pharma® Roundtable Breakfast Session: Balance for Better in Biopharmaceutical Manufacturing.

Vivianne Arencibia


Exciting kick off to day 2 of the 2019 ISPE Global Pharmaceutical Manufacturing Summit with the Women in Pharma® Roundtable Breakfast Session: Balance for Better in Biopharmaceutical Manufacturing.

Speakers included:

  • Jennifer Lauria Clark, CPIP, Executive Director, Strategic Development Commissioning Agents, Inc. Vivianne Arencibia, Independent Consultant, Arencibia Quality Compliance Associates
  • Alice Redmond, PhD,Vice President, European Operations, CAI
  • Tara Gooen Bizjak, CDR, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, CDER, FDA
  • Richard (Rik) Lostritto, PhD, Associate Director for Science, Office of Policy for Pharmaceutical Quality, CDER, FDA
  • 2019 ISPE Global Pharmaceutical Regulatory Summit
  • 2019 ISPE Global Pharmaceutical Regulatory Summit
  • 2019 ISPE Global Pharmaceutical Regulatory Summit
  • 2019 ISPE Global Pharmaceutical Regulatory Summit

From your experience with Case for Quality, what would you change or improve with the CMMI approach?

Hear Laura Corrado, Director, Quality System Improvements & Integrations, Johnson & Johnson, response to this question during the APQ Quality Maturity Frameworks session.


Advance Therapy Medicinal Products such as CAR-T cells, Tissues, and gene therapies are exciting additions to the traditional pharmaceutical options. However, their complexity can require innovative regulatory thinking with regard to quality assurance, cGMPs, and process validation.

A few slides from Dr. Mehrshid Alai-Safar, Vice President, Regulatory CMC, Kite Pharma, Inc., presentation on Yescarta’s Journey and Beyond.

  • 2019 ISPE Global Pharmaceutical Regulatory Summit
  • 2019 ISPE Global Pharmaceutical Regulatory Summit
  • 2019 ISPE Global Pharmaceutical Regulatory Summit

"Regulations are very flexible with regards to the kind of assay that can be used as long as it is measuring a meaningful biological parameter, Melanie Eacho, PhD, Chief, Cellular Therapy Branch, Division of Cell and Gene Therapies, CBER/FDA as she discussed regulatory considerations for advanced therapeutics.

Melanie Eacho


Conference Highlights