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

11:00am

#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.

Chair

Jay A Turpen

Speaker

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

Please enter Presentation Title
Lenna Kimball, MBA

Panelist
RJ Doornbos, RPh



Speakers
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 →
LK

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
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#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.

Chair

Leo Dodds, MBA

Speaker

Panelist
Judith Sernatinger, MA

Panelist
Albert Cosenza, MS



Speakers
avatar for Albert Cosenza

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
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#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.

Chair

Grace M Crawford, MS

Speaker

Panelist
Barbara Maley

Panelist
Lauren Blomberg

Panelist
Gina C Lucas

Panelist
Matthew Krumrai



Speakers
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 →
LB

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 →
GL

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
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#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.

Chair

Nancy Pire Smerkanich, DrSc

Speaker

Panelist
Eunjoo Pacifici, PharmD, PhD

Panelist
Paul W. Price, PhD, MS

Panelist
Andrew Norris, PhD

Panelist
Gary Gilleskie, PhD

Panelist
Susan E Vogel, BSN, RN



Speakers
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 →
AN

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, Department of Regulatory & Quality Sciences, USC School of, University of Southern California
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 →
SV

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
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

4:15pm

#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.

Chair

Amanda Marie Roache, MS

Speaker

Panelist
Kerstin Koenig, PhD, MSc

Panelist
Mark S. Levenson, PhD

Panelist
Joanne Palmisano, MD, FACP

EMA Update
Agnès Saint-Raymond, DrMed, MD



Speakers
avatar for Kerstin Koenig

Kerstin Koenig

Executive Director, Research and Development Quality, Merck KGaA
Kerstin Koenig, PhD is the Head of Research & Development Quality, Merck Healthcare KGaA, Darmstadt, Germany. 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 GRP, GLP... 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

Operations Research Analyst, OCD, CDER, FDA
Amanda Roache is FDA's ICH Coordinator and has served as an Operations Research Analyst in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration since 2012. Ms. Roache works in CDER's International Program and facilitates scientific exchanges with... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA