Pharma Manufacturing: From Submissions to Approval to Sustainable Global Supply

Caroline Rocks, CEng
2019 ISPE South Asia Pharmaceutical Manufacturing Conference banner

With a packed agenda of Federal and State Regulators, the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference is the conference to attend where global and local pharmaceutical companies will come together to collaborate, share experiences and advice on achieving The Quality Advantage – from Submission to Approval to Sustainable Global Supply.

The conference takes place this year in Bengaluru (also called Bangalore) which is the capital of India’s southern Karnataka state. This city is the center of India’s high-tech industry and a strong hub of pharmaceutical activity with plenty of big-name global companies like Mylan, Astra Zeneca, Allergan and Novo Nordisk with facilities here and hugely successful local companies with global supply including Biocon’s headquarters and Syngene.

Given the industry’s busy time in mergers and acquisitions, along with companies requiring the service of 3rd party manufacturers more and more to decrease time to market, improve efficiencies and reduce costs, the conference starts on Wednesday 25 September with an Executive Forum (separate registration required) on exploring the importance of effective due diligence processes to inform strategic acquisition decision making and considerations for successful third party partnerships. Successful integration of newly acquired manufacturing sites presents unique challenges and requires a multi-functional approach. From due diligence activity through the integration of various commercial and operational functions, formal governance supported by strict project management and the coordination of various subject matter experts from many different departments is required. By using a comprehensive approach, firms can successfully complete the integration of newly acquired facilities in a manner that optimizes the value of the investment and avoids any unintended complications. Executives participating in the Executive Forum will hear from and enjoy in-depth discussions with pharmaceutical industry leaders on transitioning a new acquisition into a unified quality culture.

2019 ISPE South Asia Pharmaceutical Manufacturing Conference

The 2019 ISPE South Asia Pharmaceutical Manufacturing Conference starts on Thursday, 26 September with federal and state regulators sharing recent trends in quality and compliance and case-studies by manufacturing companies. The entire conference emphasizes open dialogue to give you and your company an opportunity to help your organization.

In the afternoon, we will take a deep-dive into the opportunities to modernize approaches to commissioning and validation using the latest technologies and risk-based methods available to the industry that remain rather under-utilized. A very timely topic following the recent release of the newly updated ISPE Baseline Guide Volume 5: Commissioning and Qualification.

The first day ends with a track aptly entitled ‘Unmasking Regulatory Expectations’ where an another opportunity for Q&A and discussions between attendees and a panel of federal regulators and industry experts.

On the final day of the conference, we are excited to host a Women in Pharma (WIP) breakfast. ISPE Women in Pharma® provides women in the pharmaceutical industry a forum for connecting and collaborating on technical and career advancement topics

This breakfast session will include a panel of role model pharmaceutical leaders who will share their own career stories and insights on the global trends for females interested in engineering, including the value of achieving gender balance in the industry—right up to the Executive Suite where the gender balance gap gets bigger.

There will be no slowing down on Friday, 27 September in the ITC Gardenia Hotel with an opportunity for attendees to learn first-hand the developments in Aseptic processing and the rapid evolution of the technology together with the new regulatory expectations.  Following this, attendees will explore with us how the industry has changed over the past 5 years in its approach to data integrity from both regulatory and industry perspectives. Attendees will also have the opportunity throughout the day to catalogue the data integrity challenges faced by their organizations for discussion during this round table session.

The afternoon poses a familiar debate to industry professionals on ‘Where does GMP start?’ This session will explore the key aspects of this deceptively simple question and provide some real-life examples and guidance for those struggling with this.

We wrap up with a Closing Regulatory and Industry Panel on Submission Do’s and Don’ts, featuring experts from the US FDA, MHRA, Roche-Genentech, Cipla, and AbbVie. Get your questions addressed and engage with these insightful pharmaceutical leaders.

Every session at 2019 ISPE South Asia Pharmaceutical Manufacturing Conference includes federal and state regulators and manufacturing company representatives on each panel, don’t miss out!

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