CMC Regulatory Requirements in Drug Applications
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This training course provides a basic understanding of chemistry, manufacturing and control (CMC) requirements in drug applications. It will help prepare those in regulatory affairs to better address the key points required in the CMC sections of drug applications. Topics to be covered include CMC in investigational new drug (INDs) applications, new drug applications (NDAs), abbreviated new drug applications (ANDAs), drug master files, and post-approval change supplements. Manufacturing GMP compliance and an introduction to biological licensed application (BLA) will also briefly be discussed.
- Identify different drug applications/supplements
- Explain CMC requirements for different drug applications or supplements
- Discuss key points in preparation of CMC section for different drug applications
Agenda
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Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.
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Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Renaissance Washington, DC Downtown Hotel
999 9th Street NWWashington, DC USA
Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!
A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $317 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, August 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.
To make reservations, individuals may click on the reservation link above or call the Renaissance Washington, DC Downtown Hotel at +1 (202) 898-9000. Please make sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.
Individual Cancellation
Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival by 6:00 p.m. (EST) to avoid cancellation fees.
Please visit the hotel’s website for more information.
How to Get Here
Registration
Pricing Options
Standard Registration
Member Price
$1,399GovernmentMember Only
$839
Health AuthorityMember Only
$839
AcademicMember Only
$839
Non-Member
$1,679
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Become a Sponsor and/or Exhibitor
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Elevate your brand and maximize your exposure by becoming a sponsor at the CMC Regulatory Requirements in Drug Applications! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
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Boost your brand and visibility by becoming an exhibitor at the CMC Regulatory Requirements in Drug Applications! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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