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Advancing OINDP Test Practices East Coast Workshop

Hilton Hotel, Raleigh North Hills, N.C. April 28th, 2022

Advancing OINDP Test Practices East Coast Workshop

Apr 28 2022 8:30 a.m. to 4:30 p.m. Thursday Hilton Raleigh North Hills Hotel, 3415 Wake Forest Road, Raleigh, NC 27609

Come learn advanced testing tricks and techniques from the experts! MSP, a division of TSI, will be hosting a one day, FREE of charge event for anyone interested in furthering their understanding of current and upcoming trends in OINDP (Orally Inhaled and Nasal Drug Products) testing and analytics.

We are especially looking for scientists, lab managers or technicians who have general familiarity with using the cascade impactors and related hardware, but want to begin to think about the future and how the use of newer techniques can both save both money and time while also provide better methods, and consistent, reliable data that allows for drug development.

Please note that this workshop is provided on a first come, first served basis as space is limited - so register early. The first 20 people to register will receive a special gift!

Details

MSP experts and engineers, as well as a guest speaker from Copley Scientific, will present four sessions throughout the day: AIM Method (Abbreviated Impactor Measurements), IV-IV-c (In Vitro-In Vivo-Correlation), Automation Options, and a hands-on workshop.

Topics Topic Explanation

OINDP 101

An overview of the basics of OINDPs testing. A knowledge refresh and gap filler session.

Basic Particle Physics

There are several methods to capture and characterize aerosolized drug products.  This session will cover the basics of these techniques with an emphasis on the cascade impaction, laying the foundation for the rest of the sessions.

Keeping Up With a Changing Regulatory Landscape

Keeping up with changing regulatory landscape is of the utmost importance in the pharmaceutical industry. This session will be dedicated to discussing updates in the regulatory landscape with special attention paid to new chapters that have been added to the USP guidance for inhalation devices.

BKMs for Nasal Testing

The nasal drug product market is currently the focus of considerable research activity. Learn the DDU and APSD testing and equipment requirements.

Variability Reduction & Efficiency Improvement Strategies

The impact of variability is either a failure to achieve mass balance, meaning not all of the dose is sized, or an erroneous APSD, meaning the dose is sized incorrectly. Understand how your product testing can be optimized to reduce the risk of reduction in efficiency and cost to your organization.

Improving IVIVC Techniques

Bridging the gap between in vitro testing and the clinic is key. Find out how to implement IVIVC strategies and equipment in your R&D testing.

 

This is the session schedule for the day:

Time Focus
8:30 - 9:15 a.m. Check-In/Breakfast
9:15- 10 a.m. Session I: OINDP 101
10:00 - 10:30 a.m. Session II: Basic Particle Physics
10:30 - 10:45 a.m. Break
10:45 - 11:15 a.m. Session III: Keeping Up With a Changing Regulatory Landscape
11:15 - 11:45 a.m. Session IV: BKMs for Nasal Testing
12 - 1 p.m. Lunch
1 - 2 p.m. Session V: Variability Reduction & Efficiency Improvement Strategies
2 - 3 p.m. Session VI: Improving IVIVC Techniques
3 - 3:15 p.m. Break
3:15 - 4:30 p.m.

Hands-on demos and Q&A

4:30 p.m. Reception/Social Hour

 

Speaker Bios

Anna Sipitanou holds a BSc in Chemistry and an MSc in Drug Discovery & Pharmaceutical Sciences. Anna plays a key role in the company’s business development and application expert services, including the training of customers on a wide range of pharmaceutical testing equipment, with a particular focus on OINDP testing. She is working closely with pharmaceutical companies on a wide range of OINDP projects, using her specialist knowledge of the regulatory requirements and equipment expertise to advise customers on both delivered dose uniformity and aerodynamic particle size distribution testing, as well as in methods to improve in vitro-in vivo correlations (IVIVCs) and other specialist testing applications, including generic drug development, inhaled dissolution and facemask testing.

Matt Kerschinske is the Regional Sales Manager - Inhalation for MSP Corporation. He has a Bachelor’s degree in Biomedical Engineering from the University of Minnesota with an emphasis in medical device design. He also has previous experience in regulatory consulting writing FDA and EU applications and medical device sales.

Erik Anderson has a background in Mechanical and Industrial Engineering and is currently pursuing a Master’s degree.  Erik has played a pivotal role at MSP over the last four years working alongside companies developing inhalation pharmaceuticals, developing testing equipment products, training customers, providing regulatory guidance and other technical support.

Location/Logistics

The workshop will take place at the Hilton Raleigh North Hills Hotel, 3415 Wake Forest Road, Raleigh, NC 27609.

There are limited hotel rooms reserved for this workshop, and they are available starting Wednesday, April 27 at noon CST. The rooms are available for the discounted price of $159/night.

To register online for the discounted rate, please follow this link: 
https://www.hilton.com/en/book/reservation/rooms/?ctyhocn=RDUNHHF&arrivalDate=2022-04-27&departureDate=2022-04-29&room1NumAdults=1&cid=OM%2CWW%2CHILTONLINK%2CEN%2CDirectLink 

To register over the phone for the discounted rate, call the hotel and let them know you are with the TSI Inc. group.

 

Food/Meals 

Light breakfast, snacks, lunch and social hour will be provided for the workshop.

 

Register

Please complete the form below to register for the workshop.

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