Changes in the Global Excipient Quality and Regulatory Landscape

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 and WCC PDA

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, 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 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.

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.