What was said on the occasion

1. Opening Speech on the occasion of Discussion Forum on ICH-Q7 & Q11
at ICCBS, University of Karachi, Karachi 23rd April 2017
Roohi Bano Obaid
Member ISPE, PDA, Deputy Director, Drug Regulatory Authority of Pakistan
Bismillah hir Rehman Irr Raheem, Assalam o Alaikum
Thank you Culture of Cultivating Knowledge Team for the kind introduction. It is my great pleasure to be
here back with all of you again this month for the Discussion Forum on ICH-Q7 & Q11. In the CCK
gathering you spend your good weekend, where we together contribute a lot. This includes up to the
extent where this professional gathering identify areas of critical nature to search ways to deal
Pharmaceutical Regulatory Sciences and drug quality with the ultimate goal of patient safety in an
efficient manner than ever before. We are living in a modern, well connected, fast growing global village
of technology. Today's accomplishments in the world of pharmaceutical regulation cannot be even
imagined alone rather demands developing new ways of thinking and working for collaborative learning
of theory and bringing it in practice across cross functional multiple disciplines and real time experiences.
Realizing the seriousness of the emerging challenges such as scientific, technological, and economic are
the reasons behind to create a platform of discussion and debate among the practicing professionals. The
change we dream to see is inevitably important to put us on journey success and drive on the pathway to
survive better in time to come. Radar of time is witness of the impact generated by CCK. We received so
many calls from decision makers who were not clear about expiry dates of pellets and lyophilized
powders. They saved hundreds of millions after learning from last session and reading the document. And
I am talking about top leading pharmaceutical companies. Certainly you people did good job in
disseminating the knowledge and proven as a catalyst of change. The reason that makes the discussion
worthy is face to face meeting among different professionals of different background and regulators, it
provides opportunity to all for sharing probable consequences of concerns. It gives platform of debating
and opportunity to hear underline meaning of specific words used in the regulations or regulatory
documents. We look forward to our CCK work together, and keep continuance of progression with the
objectivity and responsible sense of emerging world that asks commitment and sincerity to keep eyes
align with the dream. I wish all the success for we all together, for our profession, for our country and
over and above for the struggle of healthier Pakistan. I am privileged and feel honored to officially open
the discussion forum. Hope you will learn a lot, will carry clear messages and expand knowledge from
today's exercise. I appreciate your worthy presence at your personal weekend, I also appreciate the
working and commitment of organizers and trainers. Have a very good day. May Allah bless all of us.
Thank You