Discussion Forum on Data Integrity & Culture of Quality Integrations at ICCBS, University of Karachi largely attended by over 100 experienced pharmaceutical professionals representing dozens of pharmaceutical manufacturing industries

1. Opening speech* at Discussion Forum on
Data Integrity & Culture of Quality Integration
(07th
July 2018 at ICCBS, University of Karachi)
Mrs. Roohi Bano Obaid
Alumni, CDER Forum of International Regulators, US-FDA, Maryland
Alumni, HPFB Forum of International Regulators, Health Canada, Ottawa
Assalam o Alaikum; Hope by the grace of Almighty Allah, you all would be doing very good. Thank you
very much of your great participation. It is my pleasure to be here this morning before you. I understand
that this time we are little late as we were moving regularly on different topics one and another since long.
Indeed, it was Ramzan, Eid holidays and end of financial year i.e. June 2018. All Saturdays and Sundays
were crossing with these days.
Let me see back and share my feelings that it is now decades, the day I have started learning
Pharmaceutical Sciences and gone through various Quality and Regulatory Affairs. I myself found it
simple and sometime it becomes more complex, it is phenomena, event and scenario that decide.
Innovations and emerging challenges of this field demand a platform of mutual discussion and smart
learning to keep system, capacity and process interface capable to speak together in an augmented way.
Safety of patients, quality and availability of drugs is a shared responsibility of everyone, no matter he is
entrepreneur or worker or government officer. CCK has developed a platform of group discussion among
subject matter experts and cross team multidisciplinary experts to manage the knowledge and worthy
experience. This way CCK intend to influence in designing simple, swift and progressive strategies to
prepare professionals, strengthen the industry and align them to respond to the fast emerging expectations
of the leading regulatory authorities in an efficient and sustainable manner.
You are aware that we wanted to have more close group discussions and training program on this topic
limited to 50 people, anyway, the interest and over whelming response pushed us to expand to 100
people, so that maximum interaction with the participants could be made possible.
Your presence encourage us and I am confident that you people are here for nothing but to share your
knowledge, strengthen your knowledge and apply in your routine operations. Dr. Obaid Ali will be
conducting session throughout the day and the session will be open to take questions and comments. I
think it is a better way for me too, to learn with all of you and today’s session. So let’s make the session
worthy and hope to be able to respond to the challenges more scientifically.
I understand that some people face hard time to manage it. Please don’t lose hope and don’t ever let
anyone make you feel like that your knowledge does not matter or your knowledge does not have place.
Be confident and be sure those who are learning and those who are not learning will not be equal. Please
accept our gratitude and let me open the session by simply saying thank you for your participation.
*Captured from her free speech to the participants