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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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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 

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

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

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199

Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199

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

Program Committee 

Previous Next


Day 1 Monday, Apr 13, 2015

  • 8:30AM - 8:45AM

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

    Session 1: Lifecycle Management
  • 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)
  • 10:45AM - 12:15PM

    Session 2C: Post-Approval - Latin America
  • 12:15PM - 1:30PM

  • 1:30PM - 3:00PM

    Session 3A: Metal Impurities
  • 1:30PM - 3:00PM

    Session 3B: Quality Metrics
  • 1:30PM - 3:00PM

    Session 3C: Post-Approval Regulatory Landscape in Asia-Pacific: Challenges to Multinational Companies
  • 3:00PM - 3:30PM

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

    Session 4: Control Strategy (DS/DP)

Day 2 Tuesday, Apr 14, 2015

  • 8:00AM - 9:30AM

    Session 5A: Continuous Manufacturing
  • 8:00AM - 9:30AM

    Session 5B: Risk-Based Review
  • 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
  • 10:00AM - 12:00PM

    Session 6B: Breakthrough Therapies
  • 10:00AM - 12:00PM

    Session 6C: Comparability Biologicals
  • 12:00PM - 1:30PM

  • 1:30PM - 3:00PM

    Session 7: Implementation of QbD
  • 3:00PM - 3:30PM

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

    Session 8A: Modelling (Chemicals)
  • 3:30PM - 5:30PM

    Session 8B: FDA/EMA QbD Pilot Program Update
  • 3:30PM - 5:30PM

    Session 8C: Risk Management for Biologicals

Day 3 Wednesday, Apr 15, 2015

  • 8:00AM - 9:30AM

    Session 9A: API Starting Materials - Implementation
  • 8:00AM - 9:30AM

    Session 9B: Pediatrics
  • 8:00AM - 9:30AM

    Session 9C: Biopharmaceutics/ Clinically Relevant Specs/ BCS Harmonization
  • 9:30AM - 10:00AM

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

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


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 Government
Member Academia
Member Standard
Member Standard (As of 03/24/2015)


NonMember Government
NonMember Academia
NonMember Standard
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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