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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 

SAVE THE DATE!
APRIL 13-15th 2015

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.

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!

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

    Speaker(s):

    • Moheb M. Nasr, PhD, MS
      Vice President, CMC Regulatory Strategy
      GlaxoSmithKline, United States
    • Ganapathy Mohan, PhD
      Head Global CMC
      Merck, Sharp and Dohme, Corp., US, United States
    • Jean-Louis Robert, PhD
      Head, Medicines Control Laboratory
      National Health Laboratory, Luxembourg
    • Christine M. V. Moore, PhD
      Acting Director, Office of New Drug Quality Assessment, OPS, CDER
      FDA, United States
  • 10:15AM - 10:45AM

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

    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, Global CMC Regulatory Affairs
      Johnson & Johnson Pharmaceutical Research and Development, United States

    Speaker(s):

    • Roger Nosal, MA, MS
      Vice President, Global CMC
      Pfizer Inc , United States
    • Christine M. V. Moore, PhD
      Acting Director, Office of New Drug Quality Assessment, OPS, CDER
      FDA, United States
  • 10:45AM - 12:15PM

    Session 2C: Post-Approval - Latin America


    Session Chair(s):

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

    Speaker(s):

    • Raphael Sanches Pereira
      Health Regulation Expert,
      Brazilian Health and Surveillance Agency, Brazil
    • Ivone Takenaka, PhD, MSc
      Associate Director, Regulatory Affairs
      Abbott Laboratories, United States
  • 12:15PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 3A: Metal Impurities


    Session Chair(s):

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

    Speaker(s):

    • Michael J. James, PhD, MSc
      Director of CMC Regulatory Advocacy and Intelligence
      GlaxoSmithKline R&D, United Kingdom
  • 1:30PM - 3:00PM

    Session 3B: Quality Metrics


    Session Chair(s):

    • Peter Carbone
      VP Global Head External Relations, Group Quality
      Novartis Pharmaceuticals Corporation, United States
  • 1:30PM - 3:00PM

    Session 3C: Post-Approval Regulatory Landscape in Asia-Pacific: Challenges to Multinational Companies


    Session Chair(s):

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

    Speaker(s):

    • Rebecca E. Komas, MS
      Director, CMC Advocacy
      GlaxoSmithKline, United States
    • Chi-Wan CHEN, PhD
      Executive Director, Global CMC
      Pfizer Inc, United States
  • 3:00PM - 3:30PM

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

    Session 4: Control Strategy (DS/DP)


    Session Chair(s):

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

    Speaker(s):

    • Stephen M. Tyler
      Director, Quality Assurance, Global Pharmaceutical Operations
      AbbVie, United States
    • Sarah Pope Miksinski, PhD
      Director, Division II, Office of New Drug Quality Assessment, OPS, CDER
      FDA, United States

Day 2 Tuesday, Apr 14, 2015

  • 8:00AM - 9:30AM

    Session 5A: 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

    Speaker(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
  • 8:00AM - 9:30AM

    Session 5B: Risk-Based Review


    Session Chair(s):

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

    Speaker(s):

    • Roger Nosal, MA, MS
      Vice President, Global CMC
      Pfizer Inc , United States
    • Diane J. Zezza, PhD
      Vice President, Global Regulatory Affairs, CMC
      Novartis Pharmaceuticals Corporation, United States
    • Sarah Pope Miksinski, PhD
      Director, Division II, Office of New Drug Quality Assessment, OPS, CDER
      FDA, United States
  • 8:00AM - 9:30AM

    Session 5C: Process Validation/Verification - Biologicals
  • 9:30AM - 10:00AM

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

    Session 6A: Process Validation/Verification - Chemicals

    Speaker(s):

    • Kevin Seibert, PhD, MS
      Senior Research Advisor, Chemical Product R&D
      Eli Lilly and Co., US, United States
  • 10:00AM - 12:00PM

    Session 6B: Breakthrough Therapies


    Session Chair(s):

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

    Speaker(s):

    • John Groskoph, MBA
      Senior Director, Global CMC
      Pfizer Inc, United States
    • Dorota Matecka
      Review Chemist
      FDA, United States
    • 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 7: Implementation of QbD


    Session Chair(s):

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

    Speaker(s):

    • Frank Montgomery, PhD
      Global Head, Regulatory CMC
      AstraZeneca, United Kingdom
    • Sharmista Chatterjee, PhD
      Chemist, Office of New Drug Quality Assurance, CDER
      FDA, United States
  • 3:00PM - 3:30PM

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

    Session 8A: Modelling (Chemicals)


    Session Chair(s):

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

    Speaker(s):

    • John Lepore, PhD
      Senior Director, Chemical Process Development and Commercialization
      Merck & Co. Inc., United States
    • Timothy J.N. Watson, PhD
      Research Fellow, GCMC Advisory Office
      Pfizer, Inc., United States
  • 3:30PM - 5:30PM

    Session 8B: FDA/EMA QbD Pilot Program Update


    Session Chair(s):

    • Ganapathy Mohan, PhD
      Head Global CMC
      Merck, Sharp and Dohme, Corp., US, United States

    Speaker(s):

    • Roger Nosal, MA, MS
      Vice President, Global CMC
      Pfizer Inc , United States
    • Christine M. V. Moore, PhD
      Acting Director, Office of New Drug Quality Assessment, OPS, CDER
      FDA, United States
    • Jean-Louis Robert, PhD
      Head, Medicines Control Laboratory
      National Health Laboratory, Luxembourg
  • 3:30PM - 5:30PM

    Session 8C: Risk Management for Biologicals


    Session Chair(s):

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

Day 3 Wednesday, Apr 15, 2015

  • 8:00AM - 9:30AM

    Session 9A: API Starting Materials - Implementation


    Session Chair(s):

    • Scott Coffey
      Director, Process Design and Development
      Eli Lilly and Company, United States

    Speaker(s):

    • John Pavey, MD
      Associate Director
      AstraZeneca, United Kingdom
    • Michael Anthony McGuire
      Team manager
      Glaxosmithkline, United States
  • 8:00AM - 9:30AM

    Session 9B: Pediatrics


    Session Chair(s):

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

    Speaker(s):

    • Gossett Campbell, PhD
      Scientific Investigator, Formulation and Process Analysis
      GlaxoSmithKline, United States
  • 8:00AM - 9:30AM

    Session 9C: Biopharmaceutics/ Clinically Relevant Specs/ BCS Harmonization


    Session Chair(s):

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

    Speaker(s):

    • Manish Gupta, PhD
      Design for Manufacture & Science Lead, USA
      GlaxoSmithKline, United States
  • 9:30AM - 10:00AM

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

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


    Session Chair(s):

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

    Speaker(s):

    • Peter Richardson
      Head of Quality, Human Medicines Evaluation Division
      European Medicines Agency, European Union, United Kingdom
    • Yoshihiro Matsuda
      Deputy Division Director, Office of Standards and Guidelines Development
      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

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

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.

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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