ISPE Chairman's Chatter

Japan Affiliate Celebrates 15 Years!

On 17 – 20 May, the Japan Affiliate held their Annual Meeting at the Toyoma International Conference Center, Toyama, Japan and celebrated their 15-year anniversary.  The meeting theme was “A Brave New World of Innovation—What Does it Hold for Us?”.   The conference was well attended, and the education presented a mixed format of plenary sessions and workshops providing an environment of learning and discussion.   The Young Professionals in Japan were represented at this event with 60+ attendees.  Future leaders of both industry and our society were engaged and eager to learn.  They were introduced to the evolution of Good Manufacturing Practices (GMP) by speaker Vasiliki Georgia Revithi (“Vee”).

ISPE Japan Affiliate Annual MeetingAs part of the anniversary celebration, several ISPE leaders were invited to smash a wooden barrel of sake to open the “After Party Celebration”.
ISPE Japan Affiliate Annual Meeting Anniversary Celebration

As is tradition, the Chairmanship of the Affiliate position transitioned at the end of the conference with outgoing Chair Shigeru Nakamura transferring responsibilities to incoming Chair Hirofumi Suzuki.   Congratulations to them both!  Also, congratulations to our Japan Affiliate for another successful Annual Meeting.

Tateyama Mountain

The end of the conference concluded with a full day tour of Tateyama Mountain.  It was magnificent!   The pictures on the internet do not do justice to the actual beauty of that region of Japan.   For example, in route to the tourist center, at the top of the mountain, we found ourselves driving on a roadway with 12 – 15-foot snow banks on either side.

ISPE Chairman Mike Arnold at Tateyama Mountain in Japan

ISPE Japan Affiliate at Tateyama Mountain

ISPE Japan Affiliate

Thank you to our Japan colleagues for a wonderful tour of the Toyama Prefecture.

Young Professionals Workshop – 21 August 2017 – Boston, Massachusetts USA

ISPE Young Professionals mark your calendars for Monday, 21 August , for an ISPE Young Professionals’ workshop to be held at Amgen in Cambridge, Massachusetts.  ISPE Headquarters will be working closely with members from our Boston Chapter for this event.  We are considering an event starting around 17:00 EST and concluding around 20:30 EST, the agenda is in its final stages of development.  The event will include two keynote speakers, workshop, social event, pizza, and beverages.   Plans are also being considered to have a conference line available for those who would like to participate remotely because they’re unable to attend in person.  More information will come from Brody Stara and Ciara Durkan.

You won’t want to miss this event!!

International Board of Directors

In the spirit of “transparency” I’d like to share some recent decisions made by the Board of Directors.

Executive Committee – Secretary Nominee

The Nomination Committee for ISPE Board Secretary proposed Thomas Hartman from GSK as the nominee.  Tom has been a Board Director for the past 3.5 years.  The proposal was reviewed and endorsed by the Board on 3 June.  Congratulations Tom Hartman!

Board Director Nominees

The Nomination Committee for the Board of Directors received several very qualified candidates for consideration. After assessments and interviews were completed, they have proposed a slate of eight very strong nominees that will be presented to the membership for election.   The Board approved the slate at the 3 June meeting.  The nominees are:

Candidate Company Location
Tony Crincoli* BMS New Jersey, USA
Flemming Dahl Novo Nordisk Denmark
Norm Goldschmidt Genesis Engineers, Inc. New Jersey, USA
Kelly Keen Roche Switzerland
Antonio Moreira* University Maryland-Baltimore Maryland, USA
Alice Redmond Commissioning Agents Ireland
Sergi Roura Grifols North Carolina, USA
Mike Rutherford Eli Lilly & Co. Indianapolis, USA

*Current Board Director seeking re-election

Congratulations and good luck to all nominees!

ISPE Foundation

The Board’s Business Development Committee has been working hard to identify new business opportunities for ISPE.  One opportunity being pursued is the establishment of an ISPE Foundation.  At the 3 June Board meeting the establishment of the Foundation was presented, discussed, and approved.  The Board directed the committee to initiate next steps.

ISPE Regulatory Steering Committee

As you heard in recent communications, we have renamed the former “Regulatory Compliance Committee (RCC)” to “Regulatory Quality Harmonization Committee (RQHC)”.  Associated with this renaming was the establishment of a “Regulatory Steering Committee” that will oversee our ISPE Regulatory Activities.  The Steering Committee will be chaired by volunteer member Dr. Roger Nosal, Pfizer. Roger will work with current leaders to identify members of the Steering Committee and begin working with ISPE leaders to develop a Regulatory Strategy for ISPE.  Welcome Roger!

Opportunities – Industry Collaboration

In the spirit of partnership, enhancing membership, and industry value, I’ve discussed with our Board of Directors, the need to seek opportunities for ISPE to work collaboratively with other “like” organizations.  There are several organizations that I will reach out to in the coming weeks to seek interest.  On 2 June, I reached out to the Parenternal Drug Association (PDA) Board Chairman, Martin Van Trieste.  Our discussion concluded favorably. Additional discussions are being planned at this time.

I will keep you informed of other discussions as they occur.

Mike Arnold - ISPE International Board of Directors Chair - Signature