Drug product formulation and control strategies discussed at PFS

SMi Reports: On Day One, the main focus points for discussion will be on drug product formulation and control strategies.

Sessions include:
Challenges and opportunities in developing a system-wide stability program for combination products
– Combination Products
– Stability Indicating Attributes
– Design Control process
– End-to-End Stability
– Drug/Biologics- Device Interactions
Alie Jahangir, Senior Manager Combination Products and Emerging Technologies, Janssen

Consideration for defining the administration procedure for nano-dose drug in clinical studies
– Adsorption phenomenon
– Dose recovery considerations
– Mitigation strategies
Michael Zhou, Investigator, Pharmaceutical- sterile CoE, GSK

Combination product risk management

– Introduction of ICH Q9 and ISO 14971
– Challenges of completing a comprehensive Hazard Analysis for combination products
– Design Risk Assessments for off the shelf components
– Integrating current drug development risk assessments to meet ISO 14971 compliance
Tanner Barnes, Design Control Engineer II, Pfizer

An early bird saving of $300 will be applied to bookings made before January 31st – interested parties can register at www.pfsamericas.com/pharmapr5

Pre-Filled Syringes East Coast

Sponsored by:

Almac | Aptar Pharma | Bold insight | Credence MedSystems | Mitsubishi Gas Chemical | Owen Mumford | PHC Corporation | Polyplastics-Topas | Steris | Weiss-Aug | Zeon Speciality Materials | Zwick Roell |


Conference: 27th – 28th April 2020

Workshop Day: 29th April 2020

Boston, USA



For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: hsidhu@smi-online.co.uk

About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk