Loading…
Attending this event?
Simple
Expanded
Grid
By Venue
10: RegCMC-Product Quality [clear filter]
Monday, June 17
 

11:00am PDT

#112: Regulatory Convergence for CMC Requirements: The Challenges and Benefits of a Single Global Dossier
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-526-L04-P; CME 1.00; RN 1.00

The session will share concrete experiences and expectations for the use of a single global dossier for CMC requirements. The panel will bring perspectives of regulators and industry, connecting the topic to regulatory convergence and reliance.

Learning Objectives

Identify the benefits of a single global dossier strategy for regulatory convergence and reliance initiatives in the area of CMC; Describe experiences from multinational companies with the implementation of harmonized dossier content for global submissions; Analyze and discuss the challenges and opportunities perceived by regulators for the use of a single global dossier for CMC requirements.

Chair

Ana Padua, MSc, RPh

Speaker

ICH M4Q(R2): Opportunity for One Global Dossier
Lawrence Yu, PhD

EMA Update
Evdokia Korakianiti, PhD, MSc

ANVISA Update
Nélio Cézar de Aquino, SR, MSc

Regional Regulatory Hub Strategist Team Lead: Specialty Care Portfolio LatAm
Agustin Brito Del Pino, RPh

Industry Update
Susanne Ausborn, PhD


Speakers
avatar for Nélio Cézar de Aquino

Nélio Cézar de Aquino

General Manager of Medicines, ANVISA, Brazil
Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Ana Padua

Ana Padua

Director EU Global Regulatory and Scientific Policy, EMD Serono, Switzerland
Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory... Read More →
avatar for Agustin Brito Del Pino

Agustin Brito Del Pino

Regional Regulatory Hub Team Lead, Pfizer Inc, Uruguay
Pharmaceutical Chemist based in Montevideo, Uruguay. +10 years of experience on the pharmaceutical industry, part of LatAm Regulatory Affairs in Pfizer since year 2014. Part of the Regional Regulatory Hub for the LatAm Region for the last 8 years. Provided strategic regulatory support... Read More →
avatar for Lawrence Yu

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

2:15pm PDT

#141: Innovation in Manufacturing Globally
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-541-L04-P; CME 1.00; RN 1.00

There is a rapid increase in the use of advanced manufacturing technologies in medicine. The session will provide an overview of the initiatives regulators take and discussion with industry on learnings and the opportunities ahead.

Learning Objectives

Describe the initiatives that regulators take to support the rapid technological growth in medicines manufacture that offers opportunities for better quality of medicines and increased robustness in supply chains leading to increased medicine availability.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

Speaker
Roberto Conocchia, MSc

EU Perspective on Enabling Innovation in Manufacturing
Marcel Hoefnagel, DrSc, PhD, MSc

FDA Perspective on Enabling Innovation in Manufacturing
Sau L Lee, PhD

Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
Gert Thurau, DrSc, PhD

Panelist
Benjamin Stevens, PhD, MPH


Speakers
avatar for Roberto Conocchia

Roberto Conocchia

GMP technical Lead, European Medicine Agency (EMA), Netherlands
Roberto Conocchia is a GMP Technical Lead at the European Medicine Agency (EMA) since March 2018. He obtained a Master degree in Bio-Chemistry from the University of Rome (La Sapienza) and a Post-graduate master’s degree in Natural substances and bio-organic Chemistry. Roberto worked... Read More →
avatar for Marcel Hoefnagel

Marcel Hoefnagel

Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Sau Lee

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States
Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
avatar for Gert Thurau

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session
 
Tuesday, June 18
 

8:00am PDT

#212: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-567-L04-P; CME 1.00; RN 1.00

The session will provide an update on ICMRA's Pharmaceutical Quality Knowledge Management project, including an overview of learnings from the pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities.

Learning Objectives

Describe the various workstreams of the ICMRA PQKM project, and their potential to support increased regulatory convergence and reliance with regards to product quality assessments and inspections; Summarise learnings arising from the ICMRA pilots on collaborative assessment of post-approval changes and hybrid inspections; Discuss potential for expansion and operationalization of the pilots.

Chair

Theresa Mullin, PhD

Speaker

Collaborative Assessment Pilot: Regulators’ Perspective
Sau L Lee, PhD

Collaborative Assessment Pilot: Regulators’ Perspective
Sean Barry, PhD

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Stelios Tsinontides, PhD, MA

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Brendan Cuddy, MSc

Pilot Programs: Industry's Perspective
Susanne Ausborn, PhD

Pilot Programs: Industry's Perspectives
Srivdya Srikant, MS

Panel Discussion: Pilot Programs
Evdokia Korakianiti, PhD, MSc

Panel Discussion: Pilot Programs
Yasuhiro Kishioka, PhD


Speakers
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Sean Barry

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →
avatar for Brendan Cuddy

Brendan Cuddy

Lead Scientific Officer, European Medicines Agency, Netherlands
Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP... Read More →
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Sau Lee

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States
Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Srivdya Srikant

Srivdya Srikant

Director, Global Regulatory Affairs- CMC, Gilead Sciences, United States
Srividya (Vidya) Srikant is a Director in Regulatory CMC (RA CMC) at Gilead Sciences Inc. Prior to joining Gilead Sciences, Vidya spent over 20 years with other pharmaceutical companies including Genzyme, Takeda, and GSK. She has extensive experience in CMC developing, managing, and... Read More →
avatar for Stelios Tsinontides

Stelios Tsinontides

Office Director, OPMA, OPQ, CDER, FDA, United States
Dr. Stelios Tsinontides is the Office Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA). OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

11:00am PDT

#232 RT: Roundtable Discussion: Innovation in Manufacturing Globally
Component Type: Session

Join the Digital Acceleration/Regulatory Affairs/Statistics & Data Science Community for a follow up round table discussion tied to session: Innovation in Manufacturing Globally (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Brett Howard, JD, PhD

Speakers
avatar for Brett Howard

Brett Howard

Senior Director, US Regulatory Policy, USP, United States
Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   10: RegCMC-Product Quality, Session

2:15pm PDT

#258 RT: Roundtable Discussion: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability (Tuesday, June 18 | 8:00am - 9:00AM PDT). Space is limited.

Chair

Demetra Macheras, MBA

Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   09: Regulatory, Session |   10: RegCMC-Product Quality, Session

3:15pm PDT

#275: Security the Chain: US Legislative Reforms, Regulatory Actions, and Recommendations to Mitigate Drug Shortages
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-607-L04-P; CME 1.00; RN 1.00

There have been many legislative and regulatory efforts in the US to address drug shortages and address assurance of supply. This session will provide an overview of these legislative and regulatory actions and provide recommendations to support drug shortage mitigation and supply chain transparency. This session will also demonstrate why addressing the issue of drug shortages is so critical, by addressing the impact of drug shortages from the patient perspective.

Learning Objectives

Define various US legislative and regulatory actions to address drug shortages and understand their impact on assurance of supply and supply chain transparency; Understand the direct impact of drug shortages to the patient; Discuss themes and industry recommendations to address drug shortage prevention.

Chair

Demetra Macheras, MBA

Speaker

Patient Perspective
Laura Bray, MBA

Industry Update
Tony Lakavage, JD

ISPE Drug Shortages Initiative: Where We Have Been and Where We Are Going
Demetra Macheras, MBA


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
LB

Laura Bray

Founder and Chief Change Maker, Angels for Change, United States
Laura Bray is Chief Change Maker and founder of Angels for Change. Founded 2019, Angels for Change is a global, volunteer-supported, non-profit organization on a mission to end drug shortages through advocacy, awareness, and a resilient supply chain. Laura has advocated for patients... Read More →
avatar for Tony Lakavage

Tony Lakavage

Senior Vice President, Global External Affairs, USP, United States
Anthony Lakavage is Senior Vice President, Global External Affairs, and Secretary, USP Convention and Board of Trustees. In his role, Mr. Lakavage oversees Global Communications, U.S. and International Public Policy and Regulatory Affairs, Global Stakeholder Engagement, Board and... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session
 
Wednesday, June 19
 

10:00am PDT

#327: Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-645-L04-P; CME 1.00; RN 1.00

This session will include the regulator and industry perspective on the Green Deal initiative and chemical agenda and will have discussions on identified case study areas of expected heavy impact where panelists from industry, SMEs, and regulators will come together to share concerns and discuss opportunities and solutions on how to manage a more sustainable and environmentally future – for example through regulatory tools which enable innovation to address the challenges.

Learning Objectives

Identify insights into how manufacturers and regulators can collaborate to deliver a revolution without risks to the supply of medicines.

Chair

Ana Padua, MSc, RPh

Speaker

EMA Update
Veronika Jekerle, PhD, RPh

Sustainability and CMC (Chemistry, Manufacturing and Controls)
Benjamin Stevens, PhD, MPH

Industry Update
Anders Vinther, PhD, MSc


Speakers
avatar for Ana Padua

Ana Padua

Director EU Global Regulatory and Scientific Policy, EMD Serono, Switzerland
Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory... Read More →
avatar for Veronika Jekerle

Veronika Jekerle

Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Veronika Jekerle hold the position as Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division at European Medicines Agency. The office manages pharmaceutical quality aspects for all human medicines across the lifecycle from early development to post-authorisation... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
avatar for Anders Vinther

Anders Vinther

Founder and Chief Executive Officer, QBA Leaders, United States
Anders Vinther, Ph.D, has established and grown companies, merged organizations, led Quality functions as Chief Quality Officer, chaired organizations and programs, and led culture change at large and small scale. Anders has more than 30 years work experience in the pharmaceutical... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

11:00am PDT

#330 RT: Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation (Tuesday, June 18 | 3:15 PM - 4:15 PM PDT). Space is limited.

Chair

Chaitanya Koduri

Speakers
CK

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   10: RegCMC-Product Quality, Session |   09: Regulatory, Session

4:30pm PDT

#376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-675-L04-P; CME 1.00; RN 1.00

This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.

Learning Objectives

Identify the key current challenges in quality control for cell and gene therapy development; Explain global regulators’ perspectives on quality control, including raw material selection, control, and qualification; Discuss best practices, including standards and reference materials, to support the development and manufacture of cell and gene therapies.

Chair

Fouad Atouf, PhD

Speaker

Qualification and Selection of Raw Materials During Early Stage of Development
Mo Heidaran, PhD

Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
Haritha Vallabhaneni, PhD

Cell and Gene Therapy Products: Global Regulatory Perspective
Michael Day, PhD


Speakers
avatar for Fouad Atouf

Fouad Atouf

Senior Vice President, Global Biologics, US Pharmacopeia (USP), United States
Dr. Atouf has over 20 years’ experience in research, product development, characterization and quality assessment of biologics including cell and gene therapies (CGT). At USP, he heads the Biologics program and oversees standards development, stakeholder engagement and external... Read More →
avatar for Michael Day

Michael Day

Senior Director, Regulatory Science, VCLS, United States
As a Senior Director, Regulatory Science and Head of Cell and Gene Therapies at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced... Read More →
avatar for Mo Heidaran

Mo Heidaran

Chief Regulatory Scientist, Cellx Inc., Consulting, United States
Dr. Mo Heidaran is currently Chief Regulatory Scientist at Cellx Inc. He previously worked as Head of Translational and Regulatory Strategy at GCTx (GC Therapeutics). He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the... Read More →
avatar for Haritha Vallabhaneni

Haritha Vallabhaneni

Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER, FDA, United States
Dr. Vallabhaneni is a CMC Reviewer in the Division of Cell Therapy 1, CBER, FDA. She is involved in CMC review of regulatory applications involving cellular therapy products. She has extensive research experience in stem cells previously working on multiple research projects investigating... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session |   10: RegCMC-Product Quality, Session
 
Filter sessions
Apply filters to sessions.
Sunday, June 16
Monday, June 17
Tuesday, June 18
Wednesday, June 19
Thursday, June 20
Ballroom
Ballroom 20 A/ Zone 1
Ballroom 20 BC/ Zone 2
Ballroom 20 D/ Zone 3
Ballroom 20 Lobby
Ballroom 6 Lobby
Content Hub Sails Pav
Exhibit Hall
Exhibit Hall B 1
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Posters Exhibit Hall
Room 11AB
Room 14AB
Room 15AB
Room 16AB
Room 17AB
Room 1AB
Room 2
Room 3
Room 5AB
Room 6A
Room 6A,Sails Pavilion
Room 6B
Room 6C
Room 6D
Room 6E
Room 6F
Room 7AB
Room 8
Sails Pavilion
TBD
USS Midway
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Focused Drug Dev
  • 06: TranslationalDelivery Tech-PrecMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Networking Opportunities
  • 20: Short Courses
  • Blood Drive
  • Format
  • Forum
  • Session
  • Tutorial
  • Workshop
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • Artificial Intelligence (AI)
  • Cell and Gene Therapy
  • Decentralized Clinical Trials (DCTs)
  • Digital Technology
  • Diversity Equity and Inclusion (DEI)
  • Ethics
  • ICH
  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD)- Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Reliance
  • Risk Management
  • Special Populations
  • Student Programming