Brainstorming Workshop on Rationality Assessment and Guidelines
for Fixed Dose Combinations

Organized by
Department of Pharmacology, All India Institute of Medical Sciences &
Central Drugs Standard Control Organization, Ministry of Health & Family Welfare
Government of India


              Venue: 25th & 26th June, 2007 Board Room, Near Director’s Office, AIIMS       


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WORKSHOP PROGRAMME

25th June 2007 (Day I - Monday)

8.30 – 9.30 AM  Registration  

Session I – Key note Address and Inauguration

9.30 AM Welcome Dr S.K.Maulik
9.35 AM  Introduction to Workshop Prof Y.K.Gupta
9.45 AM  Dean’s Remark  Prof T.D.Dogra
9.55 AM Dean’s Remark Prof R.C. Deka
10.05 AM Keynote Address Dr M.Venkateswarlu
10.20 AM Inaugural Address Dr R.K.Srivastava
10.40 AM Presidential Address Prof. N.K. Ganguly
11.00 AM  Vote of Thanks Dr Jagriti Bhatia
  Tea  

Session II – Workshop Sensitization Session

11.15 AM  Issues with FDC use in India Dr. Y.K.Gupta

FDC: Perspectives of the Stakeholders

11.30 AM Clinical Pharmacologist’s View Dr. M.U.R. Naidu
11.45 AM Clinicians’ Consideration  Dr Anoop Mishra
12.00 PM  Industry’s Angle Dr Shoibal Mukherjee
12.15 PM Discussion  
1.00 PM Lunch  

Session III – Important FDC issues

2.00 PM How does FDC affect Pharmacoeconomics?  Dr. Uma Tekur
2.10 PM  FDC and patient compliance:
Perceptions and Evidence
Dr P. Aggarwal
2.20 PM FDC use and drug resistance Dr K.K. Sharma
2.30 PM Pharmacovigilance aspect of FDC usage Dr S.K.Tripathi
2.40 PM Discussion  
  Tea  

Session IV – Criteria for assessment of safety of FDC

3.45 PM Trigger Talk Dr Y.K.Gupta
4.00 PM  Panel Discussion and Guideline Framing  
5.00 PM Disperse  
7.00 PM Round Table Dinner Discussion  
     

26th June 2007 (Day II – Tuesday)

             Session V  
9.30 AM  Recap of day I  

Session VI – Panel discussion (at 4 Different Venues)

10.00 AM Panel 1: FDC of antimicrobials as antidiarrhoeal preparations
  Panel 2: FDC of α blockers, 5α reductase inhibitors and antimuscarinics
               for treatment of benign prostatic hyperplasia
  Panel 3: FDC of COX inhibitors, analgesics, muscle relaxants and
               proteolytic enzymes for inflammation and pain
  Panel 4: FDC of proton pump inhibitors, H2 blocker, antiemetics and
               gastrokinetics for acid peptic disease
11.15 AM   Tea

Session VII – Panel Discussion (at 4 Different Venues)

11.30 AM  Panel 5:  FDC of antibiotics, analgesics, antitussives and mucolytics for
                respiratory infections
  Panel 6: FDC of β agonists and corticosteroids for asthma
  Panel 7: FDC used in the treatment of hypertension
  Panel 8: FDC of antiepleptic and antimigrane drugs
12.45 PM Lunch

Session VIII

1.30 PM Presentation by rapporteur of Session VI
1.50 PM Presentation by rapporteur of Session VII
2.10 PM Discussion on Reports
3.00 PM Preparation of guidelines for FDC
4.00 PM Valedictory Function
4.15 PM Tea
   
Note for Panel Discussion
  1. Composition of Panels: Each panel will have representation from
    1. Regulators
    2. Pharmaceutical industries
    3. Clinicians
    4. Pharmacologists
  2. The Panelists will opt for one panel in Session VI and one in Session VII depending on the choice
    and expertise.

  3. The rapporteurs of each panel will present the proceedings in the next session