To
All the Members of Council
Dear Sir/Madam,
Subject: ROUND TABLE MEETING WITH US FDA ASSISTANT COMMISSIONER on 18th March 2015, Hyatt Regency, New Delhi
Members are kindly aware that US is one of our major export destination in value terms. Pharmexcil has been in constant touch with US FDA India office for regular updates and discussion on critical issues at times for the benefits of membership and promoting greater market access in US.
US FDA is considered to be the bench mark for conformity to regulatory compliances to ensure quality, safety and efficacy of pharmaceutical products. Infact US FDA approval lends immense credibility to manufacturer/exporter in various other markets as well.
Pharmexcil is pleased to inform that a round table meet with visiting US FDA Assistant Commissioner is being organized in New Delhi on 18th March 2015.
Venue details and timings are as follows:
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Venue: Mansion-Oval Room, Hyatt Regency, Bhikaiji Cama Place, Ring Road, New Delhi 110066
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Time: 10.30- 12.30 PM followed by Lunch
We are expecting DCGI/CDSCO Officials as well to participate in the deliberation during the round table.
Broad agenda of discussions would:
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Insight into regulatory framework of US FDA
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Organising training programmes and interaction with FDA experts at various centres
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Issues and matters of concern
Keeping in view the importance of US market and as a national body representative of entire Indian pharma export sector, it is proposed to provide opportunity to all industry associations and related professional bodies to present themselves appropriately in the meeting with senior dignitary of US FDA. The following associations are therefore requested to nominate their members from each organization.
1. IPA
2. IDMA
3. BDMA
4. ABLE
5. ADMA
6. FOPE
7. ISPE
8. PDA
9. Members of CoA
10.Select members of Pharmexcil
We take this opportunity to invite interested CEOs/MD and top representatives of your Organisations to participate in the proposed meeting. Since the number of seats are limited and only restricted to companies having USFDA approval, you are kindly requested to confirm your participation by return e-mail on rodelhi@pharmexcil.com with a copy to dg@pharmexcil.com before 10th March 2015.
In order to structure the meeting and achieve best possible constructive discussions, we would kindly request to forward your suggestions and matters of concern to Pharmexcil on dg@pharmexcil.com with a copy to rodelhi@pharmexcil.com
Looking forward to your kind confirmation.
With best regards
Dr P V Appaji
Director General