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08: R-D Quality-Compliance [clear filter]
Monday, June 24

11:00am PDT

#115: Quality Management Post-Quality Management System Implementation In The Wake of ICH E6 (R2)
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-529-L04-P; CME 1.00; IACET 1.00; RN 1.00

The key characteristics of a QMS with a focus on how the size of an organization impacts the QMS characteristics and their risk-based methodologies, including what key learnings organizations of varying sizes can learn from each other’s experiences.

Learning Objectives

Discuss the differing characteristics of a QMS based on the size of the organization; Compare how these characteristics changed in preparation for ICH E6 R2 implementation; Determine whether risk-based approaches vary based on organizational size and what organizations of different sizes can learn from each other.


Jay A Turpen


Assessing Your Clinical Quality Management System: A Comprehensive Review of TransCelerate’s CQMS Assessment Tool
Michael Husovich

Please enter Presentation Title
Lenna Kimball, MBA

RJ Doornbos, RPh

avatar for Michael Husovich

Michael Husovich

Director, Global R&D Quality, Amgen Inc.
Michael is currently Director of Global R&D Quality Operations at Amgen. Michael is responsible for advancing Amgen's R&D Quality Management System including Business Process Management, Document Management, Issue CAPA Management, Quality Risk Management and driving Operational Excellence... Read More →

Lenna Kimball

Vice President of of Clinical Operations, Lyell Biotech
avatar for Jay Turpen

Jay Turpen

Senior Consultant, The Avoca Group
Jay Turpen is a Senior Consultant with The Avoca Group. He has been in the pharmaceutical industry for 30 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new... Read More →
avatar for RJ Doornbos

RJ Doornbos

Head of Global Quality Systems, Global Quality, Bristol-Myers Squibb Company
RJ Doornbos has over 25 years experience in Pharmaceutical Industry in Brand and Generic concentrated in the areas of GxP Quality, Regulatory Affairs and Pharmaceutical Sciences. She has held various roles in Schering-Plough, Merck, Allergan/Teva and more recently in BMS where she... Read More →

Monday June 24, 2019 11:00am - 12:00pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Forum

2:15pm PDT

#145: Examining Essential Elements of Vendor Governance and Comparing Perspectives of Large and Emerging Biopharma
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-545-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present pillars of effective vendor oversight and governance. A panel of experts will provide perspectives on benefits, lessons learned and challenges of various models.

Learning Objectives

Discuss the importance of comprehensive and transparent vendor oversight in light of increasing partnerships and outsourcing; Identify and review real life examples of issues and how to effectively address in both new and ongoing vendor relationships; Discuss ways to improve and accelerate trust in relationships.


Leo Dodds, MBA


Judith Sernatinger, MA

Albert Cosenza, MS

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Albert Cosenza

Head, Vendor and Capacity Management, Johnson & Johnson
A Pharmaceutical executive with a passion for building successful partnerships between vendors and corporations. As the cross-sector head of vendor and capacity management, he is responsible for providing strategic leadership for vendor management and oversight, as well as capacity... Read More →
avatar for Leo Dodds

Leo Dodds

Partner, Triradial Solutions
A biopharma executive and management consultant with a background in statistics and business operations. Leo helps clients accelerate their success strategies through leading practice and experience-based methods. His experience spans both commercial and R&D operations and his focus... Read More →
avatar for Judith Sernatinger

Judith Sernatinger

Vice President, Global Head of Quality, Prothena Biosciences Inc
Judith is a Quality Management Executive recognized for her ability to collaborate to build quality organizations and processes that drive patient safety and product quality. As VP, Global Head of Quality at Prothena Biosciences, she is responsible for Quality strategic planning and... Read More →

Monday June 24, 2019 2:15pm - 3:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Forum

3:30pm PDT

#164: Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-561-L04-P; CME 1.00; IACET 1.00; RN 1.00

The importance of periodic screenings (e.g. assessments, mock inspections) to ensure good inspection health. An interactive and colorful discussion of how being prepared by getting a thorough ‘check-up’ is the best way to be ready for an inspection.

Learning Objectives

Demonstrate how periodic screenings are an important part of inspection readiness; Discuss where hidden challenges lurk and how mock inspections can bring these items to light; Identify appropriate remediation plans that are organizationally focused and not study specific.


Grace M Crawford, MS


Barbara Maley

Lauren Blomberg

Gina C Lucas

Matthew Krumrai

avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality and Compliance, AstraZeneca
Grace joined MedImmune in April 2015 to lead the Clinical Quality & Compliance function. Prior to joining MedImmune, Grace spent over 21 years at ICON where her main focus was leading the Clinical QA Department. She is active in industry participating in forums such as the Society... Read More →
avatar for Barbara Maley

Barbara Maley

Sr. Consultant, The Avoca Group
Barb Maley is a Quality Assurance professional with 29 years of research experience including 26 years within the pharmaceutical industry (GLP and GCP) and 17 years hands-on experience within Quality Assurance and Continuous Improvement. Barb has extensive experience providing quality... Read More →

Lauren Blomberg

GCP Inspection Lead, Quality and Continuous Improvement, GCTO, Merck & Co., Inc.
Lauren Blomberg is an Associate Director, GCP Inspection Lead within the Global Clinical Trial Operations department at Merck & Co., Inc. Lauren has over 10 years of GCP and PV experience in the pharmaceutical industry, with expertise in Inspection Preparation and Inspection Management... Read More →
avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →

Gina Lucas

Director, Strategic Advice, AstraZeneca Pharmaceuticals LP
Gina Lucas is a professional with over 25 years of GXP QA pharmaceutical industry experience. Her current role includes providing GCP strategic direction for Immuno-oncology programs at AstraZeneca including providing quality and compliance advice during study conduct, submission... Read More →

Monday June 24, 2019 3:30pm - 4:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Forum
Tuesday, June 25

8:00am PDT

#212: Translating Academic Research into Product Development: Integrating GXPs into the Process (Part 1 of 4)
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-580-L04-P; CME 1.25; IACET 1.25; RN 1.25

This is the kickoff to a GxP series on the importance of implementing quality standards in early drug development conducted in academia and start-ups that govern how a compound is to be manufactured, tested in animals and studied in clinical trials.

Learning Objectives

Define GxP, G(R)P, GMP, GTP, GLP, and GCP; Discuss the importance of GxPs in manufacturing and translational research; Identify the challenges of implementing GxPs in an academic research and development environment.


Nancy Pire Smerkanich, DrSc


Eunjoo Pacifici, PharmD, PhD

Paul W. Price, PhD, MS

Andrew Norris, PhD

Gary Gilleskie, PhD

Susan E Vogel, BSN, RN

avatar for Gary Gilleskie

Gary Gilleskie

Acting Director, Biomanufacturing Training and Education Center, North Carolina State University
Dr. Gary Gilleskie has been with NC State’s Biomanufacturing Training and Education Center (BTEC) since 2007 and is currently BTEC’s Acting Director. Gary’s work at BTEC focuses on downstream processing of biopharmaceuticals, including protein therapeutics, vaccines, and gene... Read More →

Andrew Norris

Director of Research, BCN Biosciences
Dr. Andrew Norris has a varied background in both business and the technology sector. He is co-founder of The Midvale Group LLC in 2002, consulting in both the technology and biotechnology sector. Dr. Norris has also co founded BCN Biosciences, a company with principal focus in the... Read More →
avatar for Eunjoo Pacifici

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California
Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... Read More →
avatar for Paul Price

Paul Price

Regulatory Officer, Office of Regulatory Affairs, DAIT, National Institute of Allergy and Infectious Diseases, NIH
Dr. Price is a Regulatory Officer with NIH, NIAID, DAIT, ORA . Paul received his Ph.D. in Biology (Immunology) from Georgetown University, and completed post doctorate training at the Department of Microbiology and Immunology, University of MD School of Medicine. Paul has over 35... Read More →
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →

Susan Vogel

Clinical Research Oversight Manager, National Institute of Allergy and Infectious Diseases, NIH
Susan Vogel is a Clinical Research Oversight Manager within the Office of Clinical Research Policy and Regulatory Operations (OCRPRO)/ Division of Clinical Research (DCR)/ NIAID/ NIH. Ms. Vogel has 18 years of experience in the clinical trials management environment and has been providing... Read More →

Tuesday June 25, 2019 8:00am - 9:15am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Forum
Wednesday, June 26

4:15pm PDT

#387: Global Perspective on ICH E8(R1): General Considerations for Clinical Trials
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-677-L04-P; CME 1.25; IACET 1.25; RN 1.25

Experts from the ICH E8(R1) working group provide an overview of the revisions to the ICH E8(R1) guideline on General Considerations for Clinical Studies and discuss how the revised guideline will support improved study design and conduct.

Learning Objectives

Discuss how the revised ICH E8 Guideline on General Considerations for Clinical Studies will modernize guidance for clinical study design; Describe how to identify critical-to-quality factors to support the meaningfulness and reliability of clinical study results; Discuss how the revised guideline will address a broader range of study designs and data sources.


Amanda Marie Roache, MS


Kerstin Koenig, PhD, MSc

Mark S. Levenson, PhD

Joanne Palmisano, MD, FACP

EMA Update
Agnès Saint-Raymond, DrMed, MD

avatar for Kerstin Koenig

Kerstin Koenig

Vice President, Research and Development Quality, Bristol Myers Squibb
Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol Myers Squibb. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Development GMP, GLP, GCP and... Read More →
avatar for Mark Levenson

Mark Levenson

Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER, FDA
Mark Levenson is the Director of the Division of Biometrics 7 in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of FDA. At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug... Read More →
avatar for Joanne Palmisano

Joanne Palmisano

Vice President, Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc
Joanne Palmisano, MD, FACP, FRAPS Dr. Palmisano is a global regulatory leader with extensive biopharmaceutical drug development expertise in small molecule and biologics in multiple therapeutic areas. As Vice President Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc... Read More →
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She supports PhRMA’s ICH efforts and leads key science and regulatory activities related to ICH, international regulatory policy and advocacy in regional platforms such as APEC, and... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Forum