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CMC Workshop 2015

Apr 13 2015 7:00AM - Apr 15 2015 12:00PM | Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Avenue Bethesda, MD 20814-5326

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Overview 

This workshop, through plenary and parallel breakout sessions, will focus on current challenging topics within the global pharmaceutical/biopharmaceutical arena. Attendees from different CMC areas will be given the opportunity to interact with representatives from global Regulatory Agencies and Industry in sessions enabling cross-functional discussions.

This program was developed by the CMC Working Group of the DIA Regulatory Affairs Community.

This program is co-sponsored by the American Association of Pharmaceutical Scientists.

Featured Topics 

Featured Session Topics:

  • Lifecycle Management
  • Post-approval Change Management Protocols
  • Elemental Impurities
  • Control Strategy Approaches for Drug Substance and Drug Product
  • Breakthrough Therapies
  • FDA/EMA QbD Pilot Program Update
  • Implementation of QbD
  • Risk Management for Biologicals
  • Updates from Regulatory Agencies (Dossier Review/Inspections)

Sessions will feature Regulatory speakers from FDA, EMA, PMDA, Health Canada and ANVISA

Who Should Attend 

Professionals involved in:

  • CMC Regulatory Affairs
  • CMC Writing
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • API Development and Manufacturing
  • Formulation Development and Manufacturing
  • Analytical Development
  • CMC Lifecycle Management
  • CMC Project Management

Special Offers 

EARLY BIRD RATE!
DIA Industry Members who register by
March 23, 2015, save $150!


Group Discounts Available!
Register 3 and Get the 4th FREE!


Special AAPS Member Discount
AAPS members can register at the discounted DIA Member rate

Hotel & Travel 

Hyatt Regency Bethesda  A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until March 22, 2015, or until room block is filled).  Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel. Contact information for Travel Planners: Attendees can follow this link to make reservations online, or call toll free in the US 1.855.355.0302 or +1.212.532.1660.When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #15004.

Standard Room Rate: $239
Hotel Address: One Bethesda Metro Center, Bethesda MD 20814

PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Ronald Reagan Washington National Airport or Washington Dulles International Airport - attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199
Rachel.Minnick@diahome.org

Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Exhibit Details
Jessica Culp, Exhibit & Event Logistics Associate 
Phone +1.215.442. 6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org 

Program Committee 

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Agenda  

Day 1 Monday, Apr 13, 2015

  • 8:30AM - 8:45AM

    Welcome and Opening Remarks
  • 8:45AM - 10:15AM

    Session 1: Lifecycle Management


    Session Chair(s):

    • Jean-Louis Robert, PhD
      Head, Medicines Control Laboratory
      National Health Laboratory, Luxembourg
    • Moheb M. Nasr, PhD, MS
      Vice President, CMC Regulatory Strategy
      GlaxoSmithKline, United States

    The concepts described in ICH Q8, Q9, Q10 and Q11 provide opportunities for a more science- and risk-based approach for developing medicinal products. However full implementation of these concepts have not been realized mainly with regards of assessing changes across the lifecycle of pharmaceutical products Several gaps exist which limit intended benefits. These gaps include criteria for a harmonized risk-based change management system that effectively evaluates the impact of change on quality, clarity of the expectations of a knowledge management system that ensures continuity of product and process information, and appropriate level of detail and information sufficient for regulatory assessment and inspection.

    Leading regulators, from Europe and United States, and industry speakers will share their perspectives on this topic and provide an update on progress made to date. Presentations will be followed by panel discussions.

    Speaker(s):

    • Lifecycle Management - ICH Q12
      Moheb M. Nasr, PhD, MS
      Vice President, CMC Regulatory Strategy
      GlaxoSmithKline, United States
    • Lifecycle Management - Industry Perspective and Case Studies
      Ganapathy Mohan, PhD
      Head of Global CMC
      Merck & Co., Inc., United States
    • Lifecycle Management - EU Perspective
      Jean-Louis Robert, PhD
      Head, Medicines Control Laboratory
      National Health Laboratory, Luxembourg
    • Lifecycle Management - FDA Perspective
      Christine M. V. Moore, PhD
      Acting Director, Office of Process and Facilities, OPQ, CDER
      FDA, United States
    • FDA Speaker Invited
      United States
  • 10:15AM - 10:45AM

    Refreshment Break/Networking
  • 10:45AM - 12:15PM

    Session 2A: Technology Transfer


    Session Chair(s):

    • Session Chair Invited
      United States

    Session 2A: Technology Transfer

  • 10:45AM - 12:15PM

    Session 2B: Post-approval Change Management Protocols (PACMP)


    Session Chair(s):

    • Thirunellai G Venkateshwaran, PhD
      Senior Director, Pharma Technical Regulatory
      Genentech, A Member of the Roche Group, United States
    • Thomas W. Schultz, PhD, MS
      Senior Director, Regulatory Sciences, Global CMC Regulatory Affairs
      Janssen Pharmaceuticals, Inc. , United States

    The focus of this session will be on post approval change management and its application for products in various stages of the lifecycle. The speakers will touch on risk based approaches to manage post approval changes and touch on various approaches used in both the generics as well as the branded pharma industry. The speakers will also touch on some of the challenges in the global implementation of changes and discuss steps that need to be taken to facilitate a consistent post approval management pathway that will enable innovation in the industry and help in the utilization of lean principles within the industry.

    Speaker(s):

    • Post Approval Change Management: FDA Perspective
      Christine M. V. Moore, PhD
      Acting Director, Office of Process and Facilities, OPQ, CDER
      FDA, United States
    • Post Approval Lifecycle Change Management - Completing What Quality by Design Intended to Deliver
      Roger Nosal, MA, MS
      Vice President, Global CMC
      Pfizer Inc , United States
    • GDUFA Impacts on Post-Approval Changes – The Real Deal
      Barinder Sandhu
      Sr. Director, Regulatory Affairs, US Generics
      Teva Pharmaceuticals, United States
  • 10:45AM - 12:15PM

    Session 02C: Case Studies and Post Approval Change Requirements in Latin America


    Session Chair(s):

    • Rebecca E. Komas, MS
      Director, CMC Advocacy
      GlaxoSmithKline, United States

    Multi-national companies are challenged with the rapidly evolving regulatory environment in Latin America. The region has diverse country specific requirements that impact NCE’s and lifecycle management of the assets. An industry speaker will present an overview of post approval changes and the impact on industry followed by an update on post approval changes, challenges with international harmonization and RDC 58 discussion presented by the Office of Evaluation of Post Approval Changes Brazilian Health and Surveillance Agency. Example case studies of simple post approval changes and the impact to industry will be presented. The session will include an opportunity for CMC experts to ask questions and discuss opportunities for convergence or regionalization of the regulatory requirements.

    Speaker(s):

    • Latin America - Post Approval Changes and the Industry Perspective
      Ivone Takenaka, PhD, MSc
      Associate Director, GRSB-CMC & LATCAN Reg Expert
      Bristol-Myers Squibb Co., United States
    • Post-approval Changes in Brazil: Current Scenario and Perspectives
      Raphael S Pereira
      Health Regulation Expert, Office of Evaluation of Post Approval Changes of Synth
      Anvisa, Brazillian Health and Surveillance Agency Brazil, United States
    • Case Study of Post Approval Changes in Latin America
      Marcio Andre Silva
      Regulatory Manager for GSK Brazil
      GlaxoSmithKline Brazil Ltda, Brazil, Brazil
  • 12:15PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 03A: Elemental Impurities


    Session Chair(s):

    • John F. Kauffman, PhD, MBA
      Deputy Director
      FDA Division of Pharmaceutical Analysis, United States

    This session will address implementation of recently developed standards and guidelines for control of elemental impurities in drug products. Topics will include implementation of ICH Q3D: Guideline on Elemental Impurities and an update on USP chapters <232> and <233>. An industry perspective on the standards and guidelines will also be presented. At the conclusion of the presentations, the panel of speakers will be available to answer questions from the audience.

    Speaker(s):

    • Danae Christodoulou
      CMC Lead
      FDA, United States
    • USP Elemental Impurities: An Update
      Kahkashan Zaidi, PhD
      Principal Scientific Liaison
      USP, United States
  • 1:30PM - 3:00PM

    Session 03B: Quality Metrics


    Session Chair(s):

    • Peter Carbone
      Novartis Pharmaceutical, United States

    Session 03B: Quality Metrics

  • 1:30PM - 3:00PM

    Session 03C: Post-Approval Regulatory Landscape in Asia Pacific – Challenges to Multi-National Companies


    Session Chair(s):

    • Chi-Wan CHEN, PhD
      Executive Director, Global CMC
      Pfizer Inc, United States

    In the rapidly growing emerging market, multi-national companies (MNCs) face tremendous challenges in ensuring that they are in compliance with regional and country-specific regulations and policies while maintaining the drug supply to patients throughout the product lifecycle. Nowhere are these challenges as pronounced as the Asia Pacific region whose 15 countries/autonomies have extremely diverse regulatory histories, systems, and capacities. This session will provide a close examination of the post-approval landscape across the region and an opportunity for MNC regulatory CMC experts to share their experiences with the audience.

    Speaker(s):

    • What is New in China?
      Chi-Wan CHEN, PhD
      Executive Director, Global CMC
      Pfizer Inc, United States
    • ASEAN Region – Is it Harmonized?
      Rebecca E. Komas, MS
      Director, CMC Advocacy
      GlaxoSmithKline, United States
    • Experiences in Other Asian Countries – Japan, South Korea, Taiwan, and Hong Kong
      Susan Stolz
      Regulatory Scientist
      Eli Lilly and Company, United States
  • 3:00PM - 3:30PM

    Refreshment Break/Networking
  • 3:30PM - 5:30PM

    Session 04: Control Strategy Approaches for Drug Substance and Drug Product


    Session Chair(s):

    • Elaine Morefield, PhD, RPh
      Senior Director, CMC Strategy, R&D
      Vertex Pharmaceuticals, United States

    This session will look at approaches to developing, maintaining and improving the control strategy throughout the product lifecycle, from a drug substance, drug product, and regulatory perspective. Following the presentations, a discussion of control strategy approaches in described situations, will allow the audience to share their insights and approaches and to ask questions of the panel members.

    Speaker(s):

    • Lifecycle Approach to Drug Substance Development
      Nick Thomson
      Director Technology API, Chemical Research and Development
      Pfizer Ltd., US, United States
    • Development and Continual Improvement of the Drug Product Control Strategy
      Stephen M. Tyler
      Director, Quality Assurance, Global Pharmaceutical Operations
      AbbVie, United States
    • Regulatory Considerations for the Development of Control Strategy
      Sarah Pope Miksinski, PhD
      Acting Director, Office of New Drug Products, OPQ, CDER
      FDA, United States

Day 2 Tuesday, Apr 14, 2015

  • 8:00AM - 9:30AM

    Session 05A: Continuous Manufacturing


    Session Chair(s):

    • Moheb M. Nasr, PhD, MS
      Vice President, CMC Regulatory Strategy
      GlaxoSmithKline, United States
    • Jean-Louis Robert, PhD
      Head, Medicines Control Laboratory
      National Health Laboratory, Luxembourg

    Session 05A: Continuous Manufacturing

    Speaker(s):

    • Regulatory and Quality Considerations for Continuous Manufacturing
      Moheb M. Nasr, PhD, MS
      Vice President, CMC Regulatory Strategy
      GlaxoSmithKline, United States
    • Regulatory and Quality Considerations for Continuous Manufacturing
      Jean-Louis Robert, PhD
      Head, Medicines Control Laboratory
      National Health Laboratory, Luxembourg
  • 8:00AM - 9:30AM

    Session 05B: Risk-based Review


    Session Chair(s):

    • Nirdosh Jagota, PhD
      Vice President Regulatory - Small Molecules
      Genentech, A Member of the Roche Group, United States

    Session 05B: Risk-based Review

  • 8:00AM - 9:30AM

    Session 05B: Risk-based Review


    Session Chair(s):

    • Kowid Ho, PharmD
      Pharmaceutical Assessor, Evaluation of Biological Products Department
      Afssaps, France

    Session 05B: Risk-based Review

    Speaker(s):

    • Integration of Control Strategy, Process Validation and Lifecycle Management for Biologics Process Validation
      Ronald Bates
      Bristol Myers Squibb, US, United States
    • Implementation of Evolving Process Validation Principles for Legacy Products
      Marco Strohmeier, PharmD
      QA Manager
      Roche Diagnostics GmbH, Germany
  • 9:30AM - 10:00AM

    Refreshment Break/Networking
  • 10:00AM - 12:00PM

    Session 6A: Process Validation/Verification - Chemicals

    Speaker(s):

    • Session 06A: Process Validation/Verification – Chemicals
      Kevin Seibert, PhD, MS
      Senior Research Advisor, Chemical Product R&D
      Eli Lilly and Co., US, United States
  • 10:00AM - 12:00PM

    Session 06B: Breakthrough Therapies


    Session Chair(s):

    • Ramesh K. Sood, PhD
      Deputy Office Director, Office of New Drug Quality Assessment, CDER
      FDA, United States

    Section 902 of the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in year 2012, provides a roadmap for expedited development and review of drugs for serious or life-threatening diseases or conditions where the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. This has provided an excellent opportunity for the pharmaceutical industry and the regulators to develop and make available medically necessary treatments to the American public. The development and approval of such therapies typically involve a rapid manufacturing development program to accommodate the accelerated pace of the clinical development.

    The regulators from the Food and Drug Administration and pharmaceutical industry speakers will share their experiences, successes and challenges faced during the development and approval process of such therapies. Presentations will be followed by panel discussions.

    Speaker(s):

    • Breakthrough Therapy Drugs: An Industry Perspective
      Brian Kelley
      Vice President, Bioprocess Development
      Genentech, A Member of the Roche Group, United States
    • An Industry Experience With Breakthrough Therapy Drugs
      John Groskoph, MBA
      Senior Director, Global CMC
      Pfizer Inc, United States
    • CMC Submission Strategies for Breakthrough Therapies: Successes and Challenges - FDA Perspective
      Dorota Matecka
      Review Chemist
      FDA, United States
    • Manufacturing Challenges for Breakthrough Therapies
      Mahesh R. Ramanadham, PharmD, MBA
      Team Leader, Office of Compliance, CDER
      FDA, United States
  • 10:00AM - 12:00PM

    Session 6C: Comparability Biologicals


    Session Chair(s):

    • Anthony Ridgway, PhD
      Senior Regulatory Scientist, Office of the Director
      Health Canada, Canada
  • 12:00PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 07: Implementation of QbD


    Session Chair(s):

    • Peter Richardson
      Head of Quality, Human Medicines Evaluation Division
      European Medicines Agency, European Union, United Kingdom
    • Frank Montgomery, PhD
      Global Head, Regulatory CMC
      AstraZeneca, United Kingdom

    Industry and Regulators have invested substantial resources in the Quality by Design project over recent years. This session will look at some of the gains that have been made for both small (chemical) and large (biological) molecules in this area and address real benefits versus expectations. The field has matured significantly with the implementation of ICH Q8, 9, 10 and 11 guidelines, however, there still remain opportunities to facilitate implementation. Recent progress in the area will be reviewed, such as outcomes from EMA QbD workshop and other FDA initiatives, with perspectives from both industry and regulators.

    Speaker(s):

    • The Present and Future of QbD for New Drugs: An FDA Perspective
      Sharmista Chatterjee, PhD
      Chemist, Office of New Drug Quality Assurance, CDER
      FDA, United States
    • Targeting “Quick but Decisive” Analytics to Support Advanced Process Controls
      Kazumi Kobayashi, PhD
      Senior Principal Scientist, Technical Development
      Biogen Idec, United States
  • 3:00PM - 3:30PM

    Refreshment Break/Networking
  • 3:30PM - 5:30PM

    Session 08A: Models, Control Strategy and Regulatory Implications: Some Thoughts and Examples from Industry


    Session Chair(s):

    • Frank Montgomery, PhD
      Global Head, Regulatory CMC
      AstraZeneca, United Kingdom

    The Points to Consider ICH Endorsed Guide for ICH Q8/Q9/Q10 Implementation describes the use of models and their categorization from high to low impact depending on level of risk to patient when used as part of the control strategy. There are a variety of ways that this information can be incorporated into the control strategy to assure product quality and process consistency as part of a marketing application. This session will look at a variety of ways that models have been used to support marketing applications, the data and statistical analysis that was needed gain approval and some considerations of how this could evolve in the future. For example a Design Space may be associated with RTRT, or may be part of a control strategy that includes extensive end-product testing; consequently the degree of assurance and the level of statistical confidence required can vary.

    Speaker(s):

    • Model Implementation: It Really Is All About the Control Strategy
      John Lepore, PhD
      Senior Director, Chemical Process Development and Commercialization
      Merck & Co. Inc., United States
    • Science and Strategy: The Role of Models in Achieving Manufacturing Flexibility
      Matt Popkin, PhD
      Product Development Global Regulatory Liaison
      GlaxoSmithKline, United Kingdom
    • Statistical Models and Tools for the Assessment of Process Parameter Criticality
      Nathan Ide, PhD
      Senior Prinicipal Scientist
      Pfizer, United States
  • 3:30PM - 5:30PM

    Session 08B: FDA/EMA QbD Pilot Program Update


    Session Chair(s):

    • Ganapathy Mohan, PhD
      Head of Global CMC
      Merck & Co., Inc., United States

    Quality by Design (QbD) has become a way of life in the pharmaceutical industry in how we develop drugs. This was piloted in the early 2000s (around 2004-2005) by the US FDA and submissions were filed by sponsors for review and approval by the US FDA. In the years since the pilot program was started, a number of continuous improvements have been made to the understanding, expectations of regulators and the implementation from the industry. However, the expectations from the regulators around the world has not been fully harmonized. In 2011, FDA and EMA announced the joint QbD Pilot Program which would help in bringing the review process closer than before between the two regulatory bodies. This session will have leading regulators, from Europe and the United States, and an industry speaker share their perspectives on this topic and provide an update on progress made to date. Presentations will be followed by panel discussions.

    Speaker(s):

    • US FDA Regulatory Perspectives of the FDA/EMA QbD Pilot Program
      Christine M. V. Moore, PhD
      Acting Director, Office of Process and Facilities, OPQ, CDER
      FDA, United States
    • Industry Perspectives of the FDA/EMA QbD Pilot Program
      Roger Nosal, MA, MS
      Vice President, Global CMC
      Pfizer Inc , United States
    • EU Regulatory Perspectives of the FDA/EMA QbD Pilot Program
      Jean-Louis Robert, PhD
      Head, Medicines Control Laboratory
      National Health Laboratory, Luxembourg
  • 3:30PM - 5:30PM

    Session 08C: Risk Management for Biologicals


    Session Chair(s):

    • Peter Richardson
      Head of Quality, Human Medicines Evaluation Division
      European Medicines Agency, European Union, United Kingdom

    This session will look at some of the issues arising in managing risks for large (biological) molecules, mainly from the perspective of QbD. ICH guidelines detail approaches to risk management, however, interpretation of these concepts have not always been consistently applied to the development of control strategies for biological substances. Of particular importance is providing assurance that Critical Quality Attributes have been appropriately identified and placed in the control strategy. Risk ranking and filtering is an important tool for this purpose, however, other tools can be employed to achieve this. Speakers with industry and regulatory experience will share their perspectives on how this may be applied for innovator and biosimilar products.

    Speaker(s):

    • Fit For Purpose Quality Attribute Risk Assessments
      Patrick G. Swann, PhD
      Senior Director, Technical Development
      Biogen Idec, United States
    • Risk Management Applied to Control Strategy
      Kowid Ho, PharmD
      Pharmaceutical Assessor, Evaluation of Biological Products Department
      Afssaps, France
    • Quality Risk Management in the Biosimilar Development
      Martin Schiestl, PhD
      Scientific & Regulatory Advisor
      Sandoz, Austria

Day 3 Wednesday, Apr 15, 2015

  • 8:00AM - 9:30AM

    Session 09A: API Starting Materials – Implementation


    Session Chair(s):

    • Scott Coffey, PhD
      Sr. Director CMC, Chorus and Global External R&D
      Eli Lilly and Company, United States

    API starting material selection and justification is a critical activity in the drug development and commercialization process. General principles for the selection of API starting materials are outlined in ICH Q11. The application of these guidelines, however, has varied from company to company, and interpretation of the guidelines by pharmaceutical companies and regulatory agencies has been inconsistent. This has led to frustration by both industry and regulatory agencies and can lead to delays in drug development timelines and to significant changes in supply chain strategies. This session will provide examples of the implementation of API starting material strategies, feedback from regulatory agencies, and a regulatory agency view on API starting materials. Time will be reserved for a panel discussion, and audience participation is highly encouraged.

    Speaker(s):

    • Definition of Starting Materials for the Synthesis of the Active Substance - The EMA View This presentation will be given via WebEx
      Session Chair Invited
      European Medicines Agency, United Kingdom
    • Science and the Supply Chain: Challenges in the Application of ICHQ11 Principles for the Selection and Justification of API Starting Materials
      Michael Anthony McGuire
      Team manager
      Glaxosmithkline, United States
    • Recent Approaches to Registered Starting Materials
      John Pavey, MD
      Associate Director
      AstraZeneca, United Kingdom
  • 8:00AM - 9:30AM

    Session 09B: Pediatrics


    Session Chair(s):

    • Peter Richardson
      Head of Quality, Human Medicines Evaluation Division
      European Medicines Agency, European Union, United Kingdom

    This session will look at some of the issues arising during development of pediatric formulations, covering industry experiences and reflecting on the regulatory requirements in both the USA and EU. Progress continues to be made in this area and EMA has recently reviewed guidance in this area at a workshop with industry. Outcomes from the workshop and how these may facilitate further evolution of this topic will be considered by speakers from both industry and regulatory authorities.

    Speaker(s):

    • Challenges Associated with Developing Medicines for Children: An Industry Perspective
      Gossett Campbell, PhD
      Scientific Investigator, Formulation and Process Analysis
      GlaxoSmithKline, United States
    • Navigating the Pediatric Formulation Landscape: “Considerations for a Successful Global Journey”
      Robert Ternik, PhD
      Senior Research Advisor
      Eli Lilly and Company, US, United States
    • Paediatric Medicines - EU Regulatory Perspective
      Piotr Kozarewicz
      Scientific Administrator
      European Medicines Agency, United Kingdom
  • 8:00AM - 9:30AM

    Session 09C: Clinically Relevant Specifications: Technical Considerations and Regulatory Expectations


    Session Chair(s):

    • Nagesh Bandi, PhD
      Director, Global CMC
      Pfizer Pharmaceuticals, Inc., United States

    Due to the critical role that dissolution plays in the bioavailability of the drug, in vitro dissolution can serve as a relevant predictor of the in vivo performance of the drug product. There is growing evidence that clinically meaningful dissolution specifications will minimize variability to the patient and therefore will optimize drug therapy. This session will discuss the relevant CMC and clinical pharmacology-related factors that should be considered in developing a clinically relevant dissolution method and specifications. In addition, the regulatory expectations and considerations will be illustrated.

    Speaker(s):

    • Novel Approaches to Better Understand Drug Product Design and Testing
      Phil D Floyd, PharmD
      Head, Analyical Development
      GlaxoSmithKline, United States
    • Strategies for Ensuring Dissolution and Clinical Performance
      Vivek Purohit, PhD
      Director
      Pfizer, Inc., US, United States
    • Clinically Relevant Specifications: FDA Perspective
      Angelica Dorantes, PhD, MSc
      Biopharmaceutics Team Leader, ONDQA, OPS, CDER
      FDA, United States
  • 9:30AM - 10:00AM

    Refreshment Break/Networking
  • 10:00AM - 12:00PM

    Session 10: Updates from Regulatory Agencies (Dossier Review/Inspections) FDA, EMA and Other Global Agencies


    Session Chair(s):

    • Moheb M. Nasr, PhD, MS
      Vice President, CMC Regulatory Strategy
      GlaxoSmithKline, United States

    Session 10: Updates from Regulatory Agencies (Dossier Review/Inspections) FDA, EMA and Other Global Agencies

    Speaker(s):

    • Speaker
      Yoshihiro Matsuda
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Exhibits  

The CMC Workshop offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop Fee $1,500

Fee Includes

  • One six-foot skirted table
  • One chair
  • Standard electricity

Attendee registration is not included in the exhibit table fee. Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates
April 13-15, 2015

Useful Links

  • DIA

Registration Fees 

Member

Member Government
$655.00
Member Academia
$820.00
Member Standard
$1490.00
Member Standard (As of 03/24/2015)
$1640.00

Non-Member

NonMember Government
$880.00
NonMember Academia
$1045.00
NonMember Standard
$1865.00
Group Discounts\Registration

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.


AAPS Discount

AAPS Members can register at the DIA Member rate – to do so, please contact Customer Service:
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
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Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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