BIOAVAILABILITY and BIOEQUIVALENCE
Expert Advisory Committee
WORKSHOP AGENDA (DRAFT)
PURPOSE: EAC - BB
PLACE: Lord Elgin Hotel, Pearson Room
DATE: June 26th, 2003
Start: 8:30 a.m. End: 4:00 p.m. |
PARTICIPANTS:
Core Members:
Dr. J.J. Thiessen, (CHAIR) ___, Dr. A. Donner ___, Dr. R. Herman___,
Dr. F. Jamali ___, Dr. E. Palylyk-Colwell ___, Dr. K. Renton ___,
Dr. D. Sitar ___
ad hoc Members:
Dr. R. Nair ___, Dr. W. Racz ___, Dr. W. Riggs ___, Dr. F. Varin___,
Mr. S. Walker___
Health Canada Representatives:
Dr. M.M. Bernard ___, Ms. L. Carter ___, Ms. L. Cockell ___,
Dr. L.N. Cui ___, Ms. M. Davis ___, Ms. C. Ficker ___, Dr. J. Gordon ___,
Dr. K. Kourad ___, Dr. C. Lourenco ___, Dr. A. Makinde ___, Dr. A. Melnyk ___,
Mr. E. Ormsby ___, Dr. C. Pereira ___, Dr. P. Roufail ___, Dr. C. Simon ___,
Ms. S. Stojdl ___, Dr. A. Tam ___, Ms. S. Wagner ___, Mr. P. Wielowieyski ___
Stakeholder Presenters:
Ms. M. Belisle ___, Dr. W. Curatolo ___, Dr. P. Keown ___,
Dr. M. Lefebvre ___, Dr. I. McGilveray ___, Dr. K. Midha ___,
Dr. C. Toal ___
ROLES
Chairperson: Dr. Jake Thiessen Primary Facilitator: Dr. Conrad Pereira
Scribe/Timekeeper: Ms. Marilyn Davis
AGENDA
| Item |
Time |
Topic and Discussion Leader |
Type* |
Outcome |
| 1 |
15 mins
8:30 - 8:45 |
Chair's address & opening remarks, adjustment of agenda Dr. J. Thiessen, Chair |
IS |
Welcome and outline meeting. |
| 2 |
30 mins
8:45 - 9:15 |
Presentation: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the
Fed State
Dr. E. Palylyk-Colwell |
IP |
Presentation of discussion paper & overview of issues surrounding requirements for food effect studies. |
| 3 |
60 mins
(total) |
Stakeholder Presentations: Requirements for Food Effect Studies moderated by
Dr. J. Thiessen |
IP |
|
10 mins
9:15 - 9:25 |
Presentation # 1
Dr. W. Curatolo
Pfizer Global Research & Development |
IP |
Allows stakeholder input and suggestions on development of Policies, leading to debate.
Strict adherence to time lines necessary. |
10 mins
9:25 - 9:35 |
Presentation # 2
Dr. M. Lefebvre
Algorithme Pharma Inc. |
IP |
10 mins
9:35 - 9:45 |
Presentation # 3
Dr. I. McGilveray
University of Ottawa |
IP |
10 mins
9:45 - 9:55 |
Presentation # 4
Dr. K. Midha
Pharmalytics Research Institute |
IP |
10 mins
9:55 - 10:05 |
Presentation # 5
Dr. C. Toal
Bayer Inc. |
IP |
| 4 |
25 mins
10:05 - 10:30 |
Coffee Break |
|
|
| 5 |
90 mins
10:30 - 12:00 |
Open Discussion on Requirements for Food Effect Studies
moderated by Dr. J. Thiessen |
|
Opportunity for EAC members, presenters, stakeholders
and observers to participate in discussion on food requirements. |
| 6 |
60 mins
12:00 - 1:00 |
Lunch |
|
|
| 7 |
30 mins
1:00 - 1:30 |
Presentation: Bioequivalence Requirements: Highly
Variable Drugs & Highly Variable Drug Products: Issues & Options
Dr. K. Midha |
IP |
Presentation of discussion paper & overview of issues
surrounding highly variable drugs. |
| 8 |
40 mins
(total) |
Stakeholder Presentations: Highly Variable Drugs
moderated by Dr. J. Thiessen |
|
|
10 mins
1:30 - 1:40 |
Presentation # 1
Ms. M. Belisle
Canadian Generic Pharmaceutical Association |
IP |
Allows stakeholder input and suggestions
on development of Policies, leading to debate.
Strict adherence to time lines necessary.
|
10 mins
1:40 - 1:50 |
Presentation # 2
Dr. P. Keown
Vancouver General Hospital |
IP |
10 mins
1:50 - 2:00 |
Presentation # 3
Dr. I. McGilveray
University of Ottawa |
IP |
10 mins
2:00 - 2:10 |
Presentation # 4
Dr. C. Toal
Bayer Inc. |
IP |
| 9 |
20 mins
2:10 - 2:30 |
Coffee Break |
|
|
| 10 |
75 mins
2:30 - 3:45 |
Open Discussion on Highly Variable Drugs
moderated by Dr. J. Thiessen |
IP |
Opportunity for EAC members, presenters, stakeholders
and observers to participate in discussion on highly variable drug
issues. |
| 11 |
10 mins
3:45 - 3:55 |
Open Discussion on BB Priorities
moderated by Dr. J. Thiessen |
IS |
Opportunity for observers and stakeholders to participate
in discussion on other BB priorities from list posted on HC Website. |
| 12 |
5 mins
3:55 - 4:00 |
Adjournment of day 1, brief comments regarding day 2
Dr. J. Thiessen |
IS |
Thanks to presenters and stakeholders and comments on
what the EAC members will attempt to do on day 2. |
Presentation times indicated are to be used as a guide and are approximate.
DAY 2
PURPOSE: EAC - BB
PLACE: Lord Elgin Hotel, Pearson Room
DATE: June 27th, 2003
Start: 8:30 a.m. End: 4:00 p.m. |
| 13 |
10 mins
8:30 - 8:40 |
Change of Name from Expert Advisory Committee to
Scientific Advisory Committee
Dr. C. Pereira |
IP |
Rationale behind this change, and its implications. Approval of amended TOR. |
| 14 |
80 mins
8:40 - 10:00 |
Requirements for Food Effect Studies
Dr. J. Thiessen |
IP |
Discussion and deliberation stemming from presentations
on day 1. |
| 15 |
15mins
10:00 - 10:15 |
Coffee Break |
|
|
| 16 |
90mins
10:15 - 11:45 |
Requirements for Food Effect Studies
Dr. J. Thiessen |
IP |
Recommendations for finalization of draft policy. |
| 17 |
60mins
11:45 - 12:45 |
Lunch |
|
|
| 18 |
75mins
12:45 - 2:00 |
Highly Variable Drugs
Dr. J. Thiessen |
IP |
Discussion and deliberation stemming from presentations
on day 1. |
| 19 |
15mins
2:00 - 2:15 |
Coffee Break |
|
|
| 20 |
75mins
2:15 - 3:30 |
Highly Variable Drugs
Dr. J. Thiessen |
IP |
Recommendations for finalization of draft policy. |
| 21 |
15mins
3:30 - 3:45 |
Future Agenda Item Proposals
Dr. J. Thiessen |
IP |
General discussion by members and HC regarding priorities
that should be discussed at next meeting. |
| 22 |
10mins
3:45 - 3:55 |
Workshop Format
Dr. J. Thiessen |
IS |
General discussion by members about workshop format...comments
what went well, what needs improvement. |
| 23 |
5mins
3:55 - 4:00 |
Adjournment
Dr. J. Thiessen |
IS |
Scheduling of next meeting. |
* Type
IS = Information Sharing Agenda Item: FYI items, no discussion,
straightforward information giving, clarification questions are appropriate.
IP = Information Processing Agenda Items: Topics requiring discussion/debate,
analysis, action planning, and/or decision making.
|
