IPEC-Americas and the West Coast Chapter of the Parenteral Drug
Association (PDA) is offering a 1- day EXCIPIENT WORKSHOP THAT WILL BE
HELD AT THE GENENTECH FACILITY LOCATED IN SOUTH SAN FRANCISCO.The
workshop is intended to provide education specifically related to
current issues related toexcipients for the respective memberships and
regulators, however, non-members are encouraged to attend as well.
There will be no charge for the workshop for IPEC-Americas, PDA
members and regulators, and a nominal fee for non-members.
The program will highlight the following topics:
* The Impact of Composition and Excipient Variability on QbD and Drug
Performance
* Chinese Pharmacopeia – Changes and Impact on Excipients
* China Excipient Regulation Changes Since 2015 – Path Forward
* Excipients and Biologics
* PDA-IPEC Technical Report on Risk Assessment and the Developing
Nitrosamines Issue
* Excipient supplier approaches to providing TUPP information
* Emerging Excipient Topics such as FDA’s Draft Novel Excipient
Qualification Pilot
* Program and Excipient Contamination
It is hoped that this inaugural workshop will become an annual event,
providing outreach to the important biopharma industry.
more info and events at Ipecamericas [https://ipecamericas.org/] and
WCC PDA [http://www.wccpda.org/]
THIS EVENT IS CO-ORGANIZED BY
PROGRAM:
8:00 AM – 8:30 AM
* Continental Breakfast – sponsored by Genentech
8:30 AM – 8:45 AM
* Introduction [Janeen Skutnik-Wilkinson – Chair, IPEC-Americas;
Fabio De Martino – Chair, West Coast Chapter, PDA; Rep. from
Genentech]
8:45 AM – 9:00 AM
* The Impact of Composition and Excipient Variability on QbD and Drug
Performance [David Schoneker – Vice Chair of Science and Regulatory
Policy, IPEC-Americas; Global Expansion Coordinator, IPEC Federation]
9:00 AM - 09:45 AM
* China Excipient Regulation Changes since 2015 – Path Forward
[Priscilla Zawislak – Past Chair, IPEC-Americas, Current Chair, IPEC
Federation ]
9:45 AM - 10:15 AM
* BREAK – sponsored by Millipore Sigma
10:15 AM – 11:00 AM
* Excipients and Biologics [Janeen Skutnik-Wilkinson – Chair,
IPEC-Americas]
11:00 AM – 11:45 AM
* PDA-IPEC Excipient Risk Assessment Guide & the Developing
Nitrosamines Issue [Janeen Skutnik-Wilkinson – Chair, IPEC-Americas]
11:45 AM – 1:00 PM
* LUNCH – sponsored by Genentech
1:00 PM – 2:30 PM
* Excipient Manufacturer’s Perspective on Best Practices on
Excipient Quality:
*
*
* Introduction of MilliporeSigma – Bretta Lichtenhan,
MilliporeSigma
* Supplier’s Approach to Technically Unavoidable Particle Profile
(TUPP) Information – Mike Polito, MilliporeSigma
* Critical Quality Attributes and how they improve development of
Excipients - Michelle Quinn, MilliporeSigma
2:30 PM – 3:00 PM
* BREAK – sponsored by Millipore Sigma
3:00 PM – 4:30 PM
* Emerging Excipient Topics
*
*
* Novel Excipient Qualification Program with FDA – Nigel Langley,
Vice Chair Maker and Distributor Relations, IPEC-Americas
* Panel Discussion Q&A on Emerging Excipient Topics – All Speakers
4:30 PM – 6:00 PM
* Networking Reception – sponsored by Millipore Sigma
EVENT SPONSORS:
FAQS
HOW CAN I CONTACT THE ORGANIZER WITH ANY QUESTIONS?
You can contact the event organizer sending an email to
rsvp@wccpda.org [http://wccpda.org], please allows few days for the
response, emails will not be monitored on the day of the event.
WHO CAN I CONTACT IF I AM NOT ABLE TO LOCATE THE EVENT VENUE AND/OR I
CANNOT ACCESS THE BUILDING?
If you need support on the day of the event for building access or
location call 6502968044
IS MY REGISTRATION FEE OR TICKET TRANSFERABLE?
Ticket is not reimbursable, however you can transfer it by 25FEB20 to
whoever would like to attend in your behalf
I AM PLANNING TO DRIVE, ANY INFO ON PARKING?
Parking will be available to the external guests in the following
visitor parking lots close-by the workshop venue in building 24, (305
DNA Way, South San Francisco, CA 94080): Visitor Lots 25, 31 & 35
No physical parking passes will be needed as Genentech security will
have your car information, if communicated during your registration
Car info need to be communicated to rsvp@wccpda.org
[http://wccpda.org] before 26FEB20
If you have NOT communicated your car info via email or during your
online registration before 26FEB20, you will have to communicate them
to Genentech Security during your check-in (it is your responsibility
and interest to do it, the workshop organizers will not be responsible
for any fine or tickets or other events/disputes about your car on the
Genentech premises)
IS IT POSSIBLE TO GET A PASS FOR THE GENENTECH BART SHUTTLE?
It will be your responsibility to arrange your commute. As far as we
are aware the Genentech Bus from Glen Park Bart Station doe not
require a pass, all other buses do require a pass. We cannot provide
bus passes or time tables .
We cannot provide passes for any other Genentech busses.
I AM NOT FROM THE AREA, WHAT ARE MY HOTEL OPTIONS IN SOUTH SAN
FRANCISCO?
* Embassy Suites by Hilton San Francisco, 250 Gateway Blvd, South San
Francisco CA 94080
* Hilton Garden Inn San Francisco Airport North, 670 Gateway Blvd,
South San Francisco, CA 94080
* Residence Inn by Marriott San Francisco Airport/ Oyster Point
Waterfront (this is where I stay mostly), 1350 Veterans Blvd, South
San Francisco, CA 94080
* AC Hotel by Marriott San Francisco Airport – oyster point
waterfront, 1333 Veterans Blvd, South San Francisco, CA 94080
* Courtyard by Marriott San Francisco / Oyster Point Waterfront, 1300
Veterans Blvd, South San Francisco, CA 94080
* Doubletree by Hilton San Francisco, 5000 Sierra Point Pkwy,
Brisbane, CA 94005
WHAT IS THE DRESSING CODE?
Business casual
Cancellation Policy:
Dinner seating is confirmed and reserved in advance. We regret that no
refunds can be offered for non-attendance. If a registrant cannot
attend, substitutions are welcome by 25FEB20. The chapter reserves the
right to cancel a dinner meeting if the minimum number of attendees is
not met by Monday prior to the event. The chapter reserves the right
to not answer emails or phone calls on the day of the event
Privacy Policy:
We manage your personal data responsibly and align with PDA privacy
policy [http://pda.org/privacy-policy].
REGISTRATION AGREEMENT: by registering to this event I consent the WCC
PDA and Ipec-americas to record and/or photograph me and using those
recording and/or photographs in the future WCC PDA promotional and
marketing material, and to send me promotional information via email.
culture
540
Views
05/03/2020 Last update