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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Summary of Meeting, September 17, 2008 - Menveo

Summary of Meeting
Discussion points are in italics.
17Sept08, 3:00 pm WOC – 1

BLA 125300_0
Novartis ACYW-135 Mening Vaccine
C. Fiore – Primary Reviewer

  1. Introductions

We went around the room and introduced all present committee members.  The attendees are listed below:

Al-Humadi, Nabil  x - Tox
Austin-Hansberry, Lori  x - OBE - reg coor
Bash, Margaret  x - Clin
Blake, Milan x  - DBPAP Dir (cc)
Burns, Drusilla - Assay Validation
Campbell, Karen x- DPQ
Devore, Nicole x - Prod coord trainee
Fiore, Cara x - RPM
Freedberg, Daron x - Product
George, Joseph x - Facilities
Green, Martin (Dave)                  Tox Chief (cc)
Gruber, Marion - Repro tox
Krasnicka, Barbara x - Stat
Lee, Martha x - Stat – assay
Lee, Robert x - Product
Lynch, Christian x -hSBA Product
Meysick, Karen x - Assay Validation
Miller, Catherine x- APLB
Pratt, Doug - Clin Chief (cc)
Richman, Paul- Branch Chief (cc)
Roecklein, Tina x - Product Coord
Schwab, David- Elect. Integ
Sutkowski, Liz              (Branch Chief)
Sun, Wellington - Div Dir  (cc)
Trudel, Nicole x - Facilities
Vann, Willie x - CHAIR
White, Janet- BIMO
Wise, Robert- OBE
Woo,Jane x - PMS
Shone, Deanna x - dvrpa
McCormick, Bill X - DPQ

 

  1. Monthly team Meeting (telecon/face to face)

Future meetings will be via telecom or face to face, unless there are urgent issues that require extensive discussion (ie – that may be face to face only.)

  1. FDAAA – what it mean to reviewers – moves schedule up.  Documentation is are posted on the web, PMC, labeling, etc (see “FDAAA Implementation” on our intranet). 

The facilities reviewer and the Chair clearly state the review deadlines may not be attainable.  This is a point of concern for the primary reviewer and she will further explore these dates with management. These dates were set by a pre-programmed Gannt chart on BLA timelines in draft form by OVRR in order to conform with FDAAA. 

  1. Documents – Reviews, memos, telecons, emails, meetings summaries, etc.

    1. All deadlines include uploading signed, certified pdf with attached Word doc into EDR.  See instruction handout.  If you have problems, please email david.schwab@fda.hhs.gov and cc me (cara.fiore@fda.hhs.gov).

Please do not upload any document without the stamp, attached Word doc and certification.  Deanna Shone is here to answer any questions, as well as I have provided you with a hand out.

  1. Communication with sponsor

Please include the primary reviewer on all communications.  If you request Cara to set up a telecom, and therefore she sit in on it to assure proper documentation of the communication.  There are a couple exceptions that are listed in the BLA SOPP.

  1. Committee assignments, Roles  and Responsibilities (SOPP 8401)

Al-Humadi, Nabil- Tox
Austin-Hansberry, Lori- OBE - reg coor
Bash, Margaret- Clin
Blake, Milan-DBPAP Dir (cc)
Burns, Drusilla- Assay Validation
Campbell, Karen- DPQ
Devore, Nicole- Prod coord trainee
Fiore, Cara- RPM
Freedberg, Daron- Product
George, Joseph- Facilities
Green, Dave                  Tox Chief (cc)
Gruber, Marion- Repro tox
Krasnicka, Barbara- Stat
Lee, Martha- Stat – assay
Lee, Robert- Product
Lynch, Christian x -hSBA Product
Meysick, Karen- Assay Validation
Miller, Catherine- APLB
Pratt, Doug- Clin Chief (cc)
Richman, Paul- Branch Chief (cc)
Roecklein, Tina- Product Coord
Schwab, David- Elect. Integ
Sun, Wellington - Div Dir  (cc)
Trudel, Nicole- Facilities
Vann, Willie- CHAIR
White, Janet- BIMO
Wise, Robert- OBE
Woo, Jane x - PMS
 

  1. Major Due Dates are on Table below

  1. Responsibilities

Milestones

Date

STN Assignment

11Sept08

Committee Assignment

11Sept08

1st Committee Meeting

17Sept08

VRBPAC  Determination

12Oct08

Filing Meeting

>13Oct08

PeRC – schedule pres. If needed

27Oct08

Filing Action

>28Oct08

Deficiencies identified

>11Nov08

Draft Reviews Due/Mid Cycle review

25Jan09

VRBPAC planning meeting

26Nov08

PREA determination

25Jan08

Final Reviews Due

26Mar09

PMC to FDAAA Safety WG

06May08

Package to Branch Chief

27May09

Final Action Due Date

29Jun09

Action Package Posting

01Jul09

Monthly Meetings (Team)

Every Month

IOD Monthly Update (WV/CF)

Every Month

  1. Questions/Comments/Concerns?

None.  The Chair added no comments. The meeting ended at 3:25.