Chairman's Chatter: April Showers Success Through These Highlighted ISPE Events

Boston Chapter Celebrates 25 Years!

On 27 April, more than 200 people attended Boston Chapter’s 25 Year Anniversary celebration at the InterContinental Hotel in Boston, Massachusetts.  Consistent with the Chapter’s history, it was classy and very well done.  It was an excellent opportunity to engage with those responsible for the success and accomplishments of the Boston Chapter.  Current President, John Spohn welcomed the celebrants, provided a chronological history of the Chapter, and thanked all those involved in its evolution. Members and other attendees listened to two keynote speakers:

• Ronald J. DeBellis, Chief Scientific Officer, NORD (National Organization for Rare Diseases)
• Christopher Love, Associate Professor Chemical Engineering, Massachusetts Institute of Technology

The evening concluded very nicely with Taylor Swift’s song, “You Belong to Me”. Check out the video. Congratulations Boston Chapter—Here’s to another 25 years!

ISPE Quality Culture Conference – a Resounding Success! 

On 25 – 26 April, at the Marriott Hotel in Bethesda, Maryland, Co-Chairs Nuala Calnan and Matt Pearson facilitated a well-attended conference on Quality Culture.  Attendees, pharmaceutical industry leaders and regulators, were very engaged in all aspects of the dialogue.  The conference was composed of keynotes, workshops, and a panel of pharmaceutical industry leaders talking about their success and challenges in establishing quality culture within our industry. “What an excellent conference! The breadth and depth of new content and the engagement were second to none.  The Cultural Excellence Team, under the inspirational leadership of Nuala and Matt, delivered a conference that needs to be a roadshow!” ~ Mairead Goetz, ISPE Quality Metrics Team Leader “Congratulations on a very successful and substantive conference on quality culture and quality metrics these past two days.  I got a lot of recharged energy and conviction, even though I have always known and am passionate on how important building a robust quality culture is for companies to succeed.” ~ Louis Yu, Chief Quality Officer, Valeant My congratulations to the Program Committee on delivering another successful ISPE event!

ISPE Core Values

Co-Chairs, Diane Munda and Susan Obarski, facilitated a review and update of ISPE’s organizational values. ISPE previous set of core values was last updated in 2006 and was not being used. The headquarters goal of this effort was to create a set of values that would support a collaborative culture and provide a positive impact in the work environment. All staff provided input into this process and the core values team shaped that input into the new core values.  Check out the new ISPE core values:

Accountability

We accept responsibility for our work and learn from our mistakes. We honor our commitments and will take personal responsibility to help achieve the desired results.  We proactively work to overcome obstacles. We learn from our mistakes and use them as an opportunity for improvement.We accept responsibility for our work and learn from our mistakes and use them as an opportunity for improvement.

Collaboration

We work together to achieve our goals. We are a global team united by a common purpose as defined in the strategic plan.  We encourage open communication, coordination, and team-based approaches to achieve goals.

Professional Excellence

We deliver quality work and are open to exploring and trying new things. We deliver quality work through our competence, commitment to continuous learning, and motivation to achieve the Society’s goals.  We will be fearless in pursuing new approaches that help us achieve our goals.  We embrace change for the opportunities it brings.

Integrity

We are honest, fair, and ethical. We conduct our business with the highest standard and professionalism.  We are transparent, honest, and ethical in all our interactions with one another, our members, and others.

Respect

We embrace diversity, provide support, and encourage one another. We recognize that diversity in thoughts, opinions, and backgrounds contributes to making us a stronger team.  We approach one another with open minds and in a way that promotes positive interactions. The core values are now the foundation of ISPE’s operations. A peer-to-peer recognition program has recently been outlined and will be rolled out later this month. This program will provide staff the opportunity to recognize their peers for exemplifying these values. Assisting Diane and Susan on the Core Team were:  David Everett, Laura Hodgson, Renee Smith, Linda Walls, and Carol Winfield. Well done everyone!

Regulatory and Compliance Committee (RCC) Gets a Face-Lift

Over the past few months, a task team of members pertaining to the ISPE RCC (Regulatory and Compliance Committee) met to review its structure.  I am pleased to share with you the outcomes of these discussions. The RCC, which will be industry lead and staff supported, has been renamed the Regulatory and Quality Harmonization Committee (RQHC) to more fully reflect its mission. The important work of the RQHC will continue to be carried out by its four Regional Focus Groups (RFGs).

• Chuck Hoiberg and George Millili will continue to chair the Global RQHC
• RFGs will continue to be led by:
  • Maurice Parlane and Chi-wan Chen in Asia-Pacific
  • Tim Watson and Eric Thostesen in North America

Additionally, we hope to soon reestablish a group in Latin America led by Marta Vidal. Vee Revithi, PhD, has been appointed to lead the EMEA RFG effective immediately.  Vee has had an excellent career as a regulator in EOF, the Medicines Authority of Greece, and in the pharmaceutical industry at Roche.  She possesses a strong quality and regulatory background and also has been an active member of PIC/S.  Vee is well respected in pharmaceutical industry and has developed an excellent regulatory network. John Berridge, PhD, also has agreed to serve as the ISPE Regulatory Consultant to the EMEA RFG.  John is respected by regulators and his pharmaceutical industry peers for his technical and regulatory experience and knowledge. As part of his independent contractor agreement with ISPE, John will act as a consultant to EMEA RFG by providing the team and Vee with administrative, technical, and regulatory support where needed. Congratulations to both Vee and John!