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CASSS Community News - March 7, 2019
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CMC Strategy Forum Europe 2019

This year's Forum will be taking place 13-15 May in Seville, Spain. The technical topics the Forum will explore are the following:

  • ICH Q12 and Post-Approval Changes
  • CMC Challenges in Accelerated Drug Approval
  • ICH Q14 / Q2 – Trends and Concepts for QbD for Analytics
  • Continuous Manufacturing for Biologics
  • Personalised Medicine and Manufacturing 4.0 for Biopharma

The following regulatory agencies will be in attendance to share their knowledge and expertise: AEMPS (Spain), BASG (Austria), BfArM (Germany), CBER, FDA (USA), CDER, FDA (USA), Danish Medicines Agency (Denmark), EDQM (Council of Europe), European Medicines Agency, FIMEA (Finland), HPRA (Ireland), Medical Evaluations Board (Netherlands), NoMA (Norway), and the Paul-Ehrlich-Institut, (Germany).


Interested in Being a Mentor?

Last year, CASSS and the Johns Hopkins University School of Medicine (JHU) Professional Development and Career Office piloted a mentor matching program to help postdocs successfully translate their research knowledge to commercial products. We are now recruiting new mentors.

Here are the Top 5 reasons for joining this year's mentoring program:

5. Shape the leaders of tomorrow. Your company's future depends on the next generation. As a mentor you gain an understanding of how younger generations see things and where they can make a difference.

4. Gain new perspectives and fresh ideas. Mentoring is a unique opportunity to step outside your normal circle of friends and co-workers to see how the world looks through someone else’s eyes.

3. Become a better leader. Leaders must a) learn to work with people to whom they don’t have a natural connection, and b) guide people to figure out the best path forward. Mentoring can hone those skills.

2. Feel good about yourself.Nurturing the next generation while improving yourself is a "win-win" for sure!

1. And the top reason to mentor is … ? Apply today and discover for yourself!

Visit the CASSS-JHU Mentor Match Program site to apply. (First-time users: register via the Non-JHED Login and go to the “Request to Join” tab to formally apply to the program.)

DC Discussion Group – Analytical QbD

Join us at the DC Discussion Group on Thursday, April 4 for an afternoon of discussion and networking. Featured speakers will include Tim Schofield, from CMC Sciences LLC, on the topic"A Lifecycle Approach to Bioassays Validation," and Jeremy Springall from AstraZeneca on "Analytical Quality by Design: What Does This Look Like?"


Registration is FREE and open until March 29. Don’t miss this opportunity to exchange new ideas and connect with colleagues!


WCBP 2019 Roundtable Notes Now Available

The WCBP Roundtable abstracts and notes are now available on the website. The Roundtable discussions have become a cornerstone of WCBP. These collegial discussions allow participants to pose questions, share insights and learn from one another.

Member Spotlight: Nadine Ritter, Vice President of the CASSS Board of Directors, member of the CASSS Associate Directors, CMC North America, and CMC Steering Committees.

The CASSS Member Spotlight is an ongoing Q&A series focused on getting to know the CASSS Community. The latest CASSS member spotlight shines on Nadine Ritter, who is also President and Principle Analytical Advisor at Global Biotech Experts, LLC.

How long have you been with your current organization and/or position?

I have been a biotech analytical and lab quality consultant, trainer, and speaker since 2002; prior to that I was director of a CRO biotech lab for several years, following six years in a large pharma company and 12 years in basic academic research. For 10 years of consulting, I worked under Biologics Consulting Group, and in 2014 I started Global Biotech Experts. (However, my friends and family would maintain that I’ve been giving my opinions on everything to everyone long before I did it professionally.)

Find out more about Nadine, her hobbies and her Cajun background HERE.

Upcoming CASSS Meetings






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