Emerging Leaders Editorial - Heather Bennett-Kelley
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Emerging Leaders Editorial: Building Consensus
Most people in their careers have to work with others at some point, and in these work interactions there are exchanges of ideas. In pushing business processes forward, determining methodology for a new experiment, or designing a manufacturing facility, multiple stakeholders come from different points of view and with varying priorities. Working with others in any capacity and having the exact...
Message From the Chair - Jörg Zimmermann
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Message From the Chair: Heading Toward a New Annex 1 and ISPE Annual Meeting
Summer is over and we are all back to our workplaces. This year has been different than the two previous years with vaccination against SARS-CoV 2 decoupling the infection rates from hospitalization, intensive-care units, and fatalities. That is an unprecedented achievement in such short time, and we as the pharmaceutical industry have helped make it happen to get back to a new normal.
Women in Pharma® Editorial: Jennifer Lauria Clark
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Women in Pharma® Editorial: Elevate Yourself with Knowledge– Or Something Else
Knowledge management is powerful. It can be a catalyst for organizational success and create a major competitive advantage, or be a major contributor to organizational failure. We live in a world today where knowledge is literally at our fingertips. To access knowledge in quite literally any topic, we Google it. Merriam-Webster has even added the word “google” as a verb to the dictionary.
Women in Pharma® Editorial: Jennifer Lauria Clark, CPIP
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Women in Pharma® Editorial: Risks & Rewards
As a part of taking care of yourself, one must risk something. For me, taking a risk can be scary. I get nervous, anxious, and, at times, begin to doubt myself. Then I remember why I’m taking a risk and what the potential rewards will be, and confidently move forward with my decision.
Emerging Leaders Editorial: New Approaches, New Tools
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Emerging Leaders Editorial: New Approaches, New Tools
Now that the year is underway and people continue to learn how to live with COVID-19, there appear to be some areas where life and work will be changed for an extended period. Adapting and coming up with new tools and approaches will be key.
Jörg Zimmermann
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Message from the Chair: ISPE News, & More
Pandemic or no pandemic, the pharmaceutical industry is growing at an unprecedented pace, and it is very gratifying to be part of that process. COVID-19 has brought our industry to the daily news, and while the public is getting a better grasp of how we work and need to work, there are still so many misconceptions that need clarification.
Emerging Leaders Editorial: Building Connection & Support
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Emerging Leaders Editorial: Building Connection & Support
The past two years have turned things upside down and forced change in a way that has made many aspects of our lives become unfamiliar. The unforeseen stresses of these changes have pushed many people and companies to their breaking points. Some of these challenges were expected, but came on like a train that we couldn’t stop. I’ve been there, feeling like I don’t have the tools to deal with...
Message from the Chair - Jörg Zimmermann
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Message from the Chair: COVID-19 - A Catalyst for Change & Progress
Who would have thought at the beginning of the pandemic that we would have several highly effective vaccines against the coronavirus and billions of doses administered by the end of 2021? I am still amazed what we as the pharmaceutical industry have achieved.
ISPE Launches ATMP Community of Practice
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ISPE Launches ATMP Community of Practice
“The only constant in life is change.” This quote is as true today as it was 2,500 years ago when Heraclitus laid out his philosophy. In the last five years, the word “cure” has been used to describe new therapies targeting many different cancer and hereditary diseases. The potential of these therapies to improve human health is profound. These breakthrough therapies utilize advancements in...
Women in Pharma® Editorial: Adapting Technology & Culture to Emerging Technologies
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Women in Pharma® Editorial: Adapting Technology & Culture to Emerging Technologies
Innovation is generally associated with driving business outcomes and processes, adapting to technology, and developing creative management approaches. In the pharmaceutical industry, innovation takes on a more extensive and specific meaning. It is acknowledged to be continuous as it involves dynamic thinking on how to integrate technology into drug development, manufacturing processes, and...
Emerging Leaders Editorial: Planning for Future Meetings - Face to Face or Virtual
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Emerging Leaders Editorial: Planning for Future Meetings - Face to Face or Virtual
Excitement for restarting face-to-face conferences is building and as plans at local and international levels are in progress, we continue to enjoy the benefits of remote interactions. Innovation and collaboration achieved through fully virtual conferences and seminars in the past year and a half show us that both have great benefits.
Message from the Chair: The Greatest Spectacle in Pharma
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Message from the Chair: The Greatest Spectacle in Pharma
I live in Indianapolis, Indiana, truly a great place to live. It is not difficult to understand why I like Indy so much: humble, down-to-earth people, farming (I grew up on a farm), readily available participant sports, and many spectator sporting event opportunities including football, soccer, baseball, and racing. Especially during the month of May, racing and the Indy 500 in particular are...
Message from the Chair: Joanne R. Barrick, RPh
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Message from the Chair: Remembering Pharma’s “Why”
Remembering the “why” of our pharma industry is so important and, for me, also very personal. My sister Linda was 69 and her four grandchildren were the light of her life. In November 2017, she was diagnosed with appendix cancer (a rare cancer, closely related to colon cancer). After four months of nasty chemotherapy, Linda entered hospice care and died the next month. Previously, my mother...
Women in Pharma® Editorial: Alice Redmond, PhD
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Women in Pharma® Editorial: Making Mentoring & Recognition More Meaningful
Organizations wanting to ensure the well-being and growth of their employees need to invest in robust mentorship and recognition programs. Mentoring has played a key role in my career development. In the 1990s and early 2000s, I worked in Novartis and engineering services companies where I was part of informal mentoring groups with some senior directors and trusted collaborators across the...
Message from the Chair: Joanne R. Barrick
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Message from the Chair: Signs of the Times
I used to think “home detention” was no punishment at all, but this last year has dramatically changed my thinking. Despite working from home for over a year, my house is a wreck! Like many of you, I feel busier than ever, despite not traveling and not driving to and from work. Disruption used to be rare and now it is common: having to adapt to new ways of doing most everything, like buying...
Emerging Leaders Editorial John Clarke Banner
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Emerging Leaders Editorial: Pharma 4.0™ - The Pillars for Success
Understanding and utilization of Pharma 4.0™ technologies will be critical for students and Emerging Leaders (ELs) as they develop in their careers in the pharmaceutical and life sciences industries. To learn more, I spoke with Edoardo Schiraldi, an Emerging Leader based in Florence, Italy, who works as a Corporate R&D Business Solutions Specialist with Menarini Group, about the “pillars”...
Message from the Chair Joanne R. Barrick banner
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Message from the Chair: Better Days Ahead
The last 12 months have felt like the slowest and fastest of times. The days drone on, yet the months fly by. I have now been working from home for a year—5% of my time at Lilly. I feel sadness for so many families who have lost loved ones and/or spent the holidays alone. Dogs and cats appearing in virtual meetings are no longer a huge distraction but a welcome glimpse of social...
Women in Pharma®: Lessons Learned
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Women in Pharma®: Lessons Learned
My parents always told me when I was growing up that I could be anything I wanted to be. They strongly steered me in the direction of engineering at North Carolina State University, so that I would be able to earn a degree that would ensure my future was my own. When I was eight years old, I was introduced to a pharma company my dad worked for and you could say my love of this industry has...
Emerging Leaders Editorial: Celebrate the Emerging New Year
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Emerging Leaders Editorial: Celebrate the Emerging New Year
I think everyone will join me in celebrating the start of 2021! With all the challenges brought by 2020, last year also demonstrated the resilience and innovative thinking of ISPE members. With collaboration and perseverance in mind, I was delighted to begin my tenure as ISPE International Emerging Leaders Chair at the virtual
Young Professional: LeAnna M. Pearson
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Young Professional: From Young Professional to Emerging Leader
As this is my last Young Professional (YP) column for Pharmaceutical Engineering®, I wanted to start with a quote from Winston Churchill that I feel summarizes my two-year journey as the International Young Professional Chair: “Success is not final, failure is not fatal: it is the courage to continue that counts.”
Frances M. Zipp - Board Chair
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Message from the Chair: That Was the Year That Was
Given the events that have transpired over the last 12 months, I have penned the title of my final column as ISPE Chair to reflect the temperament of our times. Coincidentally, and please pardon my digression, the title also happens to be the name of a hit album of topical songs by Tom Lehrer, recorded live in July of 1965 at the “Hungry I” nightclub in San Francisco, California.
Young Professional: Editorial Times Are Changing
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Young Professional Editorial: Times Are Changing
As many of you read this, I am sure your social and work life have been turned upside down, flipped around, and now are possibly settling into “the new normal.” I personally cringed when I wrote that—I was so tired of hearing that phrase about three weeks into the pandemic.
Women in Pharma® Editorial: Pandemic Coping Strategies
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Women in Pharma® Editorial: Pandemic Coping Strategies
Because of the global pandemic, we have experienced unexpected joys, learned new skills, adjusted to long days of video conferencing, and dealt with drops in income and potential job losses. At the same time, we have also experienced an increased sense of urgency, collaboration, and pride because we are a part of the industry that has been tapped to heal all our nations from this unexpected...
Message from the Chair: Pandemic Problem or Solution Opportunity?
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Message from the Chair: Pandemic Problem or Solution Opportunity?
How many times have you heard phrases like these over the last several months: unprecedented marketplace disruptions, staggering economic conditions, or maybe insurmountable business challenges? If you’re like me, probably more than you can count.
Jennifer Lauria Clark
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Women in Pharma® Editorial: Virtual Connections
How is your calendar looking these days? As I write this, we have all been living a bit differently today than we were one year ago. I’ll bet you have seen an increase in webinars, virtual trainings, and video conference calls, and likely having far fewer face-to-face interactions.
Message from the Chair: The Next Normal - Workforce of the Future
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Message from the Chair: The Next Normal - Workforce of the Future
Since January, nothing has been normal. Nothing, especially when we try to compare it to anything we have experienced in the recent past. So how do we begin to move forward as the efforts of both the public and private sectors combine to offset the advance of the impact to businesses due to COVID-19?
Women in Pharma® editorial banner
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Women in Pharma® Editorial: Find the Light, Be the Light
Did you know that Women in Pharma® (WIP) has launched a program to initiate Mentor Circles around the globe? While great strides have been made to support women in the workplace, women are still significantly underrepresented in upper management in the pharmaceutical industry. The ISPE Women in Pharma® Mentor Circle program...
Message from the Chair: The Future Belongs to All of Us
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Message from the Chair: The Future Belongs to All of Us
Spring is finally here, signaling a time of new beginnings. Today finds me thinking about International Women’s Day (IWD, observed annually on 8 March), a global day of celebrating the social, economic, cultural, and political achievements of women. This year, International Women’s Day has the theme of equality, a very fitting theme for the topics I want to share with you. This issue’s column...
Brazil Affiliate
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Benefiting from Growth Opportunities: ISPE Brazil Affiliate
Brazil’s regulatory authority is working hard to make the nation a larger player in the global pharmaceutical market, and these efforts appear to be working: the life sciences industry has expanded in recent years, and market projections are positive. These ongoing developments represent opportunities for the ISPE Brazil Affiliate as it undergoes its own transformation.
LeAnna Pearson Marcum is a Senior Project Manager at PharmEng Technology and the 2019–2020 ISPE International Young Professionals Chair
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Young Professional Editorial: Know Your Worth
I recently had dinner with a friend and colleague who was looking at taking on a new job role. She asked me what I thought about her salary request as part of this new opportunity. I asked, “Is that what you think you are worth?” She looked very confused by my response, and I realized that many of us do not often step back and determine our business value.
Frances M. Zipp - Board Chair
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Message from the Chair: Making the Connection
As I sit at my computer to write my first column as ISPE International Board Chair, my thoughts are centered on how I can personally help drive our unifying vision, “Connecting Pharmaceutical Knowledge,” and how we as members of ISPE have an outstanding opportunity in the year ahead to provide outreach and resources to expand our networks of people, technology, and information to accomplish...
Tracy Clemmer
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Multiple ISPE Roles: Lead to Unlocking Potential
Tracy L. Clemmer’s experience has spanned the globe, and she has an impressive list of ISPE roles on her résumé. In addition to being a past President and Chair of the Training and Education Committee of the ISPE Singapore Affiliate, she was a Board Member and Chair of the Training and Education Committee of the...
Article
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Leading at All Levels of Your Career
I was recently meeting with one of the individuals I am lucky enough to call a mentor and friend. During our dinner, we talked about various topics from general life items to questions about work. One of the questions she asked that inspired me to write this article was, “If leaders are people with experience and wisdom, how can I be seen as a leader when I am just starting my career?”
Pharmaceutical Engineering Online
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Pharmaceutical Engineering - Giving Thanks & Reflecting on 2019
The November-December issue of Pharmaceutical Engineering is published in the months of the Thanksgiving holiday in the US and the year-end holidays celebrated around the world, so it seems appropriate to note the many changes to the magazine this year and give thanks to those who have contributed to and supported those changes.
Article
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Networking in a Digital Age
In a world dominated by social media and online profiles, the art of getting to know someone has been transformed. So, in this age, when you can connect with someone by “swiping right” on a dating app, how do you build a professional network? Face-to-face interactions remain a great starting point. Therefore, whenever I attend a conference or other professional event, I make sure that I am...
A Year of Change
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Message from the Chair - A Year of Change
As I write my last Chairman column for Pharmaceutical Engineering, I reflect on what has happened over the past year globally and within ISPE. The pace of change in the industry has accelerated and will continue to accelerate with new technologies and business models being deployed.
Backing Biosimilars
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Backing Biosimilars
Initially, the American College of Rheumatology urged caution around the use of biosimilars. Information about the manufacturing process for a branded biologic is proprietary; a biosimilar manufacturer will not have access to the details of the process, so how could they guarantee their product would be the same? It is now well accepted by the scientific community that biosimilars are safe,...
Article
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The “F” Word: How Failure Leads to Success
From the time when we were young, we have been taught to avoid failure. You are told to get the best grades in school, which will lead to getting into college. And when you graduate, you’ll get a good job, work hard, and the promotions will come. At no point did anyone ever tell us to fail! But failure is part of life and we all have personal and professional failures despite our best...
Women in Pharma Roundtable Session
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Challenges, Strategies, & Successes at Women in Pharma Roundtable Session
Six women shared stories about building their diverse pharmaceutical industry careers, including challenges encountered along the way and their recommendations for other women in the profession, during a roundtable session on Women in Pharma®. The Roundtable opened the second day of the
Millilis Family banner
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Family Ties: Meet the Millilis
Many members think of ISPE as a family of professionals, colleagues, and friends. Two of ISPE’s active members, George and Peter Millili, have taken this a step further; they’ve made ISPE part of their family.
Article
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The Medium and the Message
Teamwork and collaboration are becoming increasingly critical in today’s professional arena. The drive to produce innovative, disruptive products calls for interdisciplinary teams. To function effectively, these diverse groups require creative problem-solving, conflict resolution, and interpersonal skills. Even the hiring process has become centered on these skills, which have traditionally...
Article
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How to Start Managing Expectations
I have always held myself to a high standard and kept high expectations for myself. I always thought that setting this high bar for myself would push me harder, make me better, and ultimately help me succeed. However, when I didn’t meet the expectations that I had set, I was so hard on myself. I would lie awake at night replaying where I went wrong over and over in my head, and all this did...
Article
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ISPE Ireland Affiliate: 30 Years & Growing
It is an exciting time for the pharmaceutical and life sciences industries in Ireland. The country has firmly established itself as one of the world’s centers of excellence and the number one European location for pharmaceutical and life science investment. It is equally exciting for ISPE’s Ireland Affiliate, which enters its 30th anniversary year as the host of the
Article
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Teamwork Unlocks Success - Lessons from the Lacrosse Field
Across industries, the trend is toward speed to market. - Whether it’s meeting consumer expectations for instant service or being the first to bring an innovation to shelves, companies have plenty of incentives to make products and services available faster.
Article
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Fishing for Biopharma Success
Maritime discipline took the Boston Area Chapter President from a trawler to the boardroom. - It might seem odd to connect commercial fishing to the study of chemical engineering— and perhaps even more unlikely to connect commercial fishing to a career in the biopharmaceutical industry. But for Kevin Chronley, Vice President...
Article
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Aeration Equipment in Aerobic Fermentation Processes
A wide range of pharmaceutical products is produced using two complex fermentation processes. Anaerobic fermentation takes place in the absence of oxygen, and aerobic fermentation requires oxygen, supplied via blower and compressor systems, to yield microorganisms and produce the desired product. This article examines the role of aeration equipment in aerobic fermentation, considerations when...
Article
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From Concepts to Reality - Meet Young Professional Richi Sethi
Richi Sethi, a Design Engineer for Biocon, India’s largest biopharma company, knows that process engineering involves constant adaptation. “We have to be very dynamic,” she explained. “People want to try new things, and we have to be on the forefront.”
Article
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Six Sigma Quality & Consortia - 2018 Continuous Manufacturing Workshop Recap
Six Sigma is an approach for pharmaceutical manufacturing quality that can help to eliminate drug shortages and recalls and improve performance issues. Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Quality, FDA Center for Drug Evaluation and Research (CDER), provided an overview of key factors around the move to Six Sigma quality in pharma manufacturing in his presentation “The...
industry demands
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ISPE Foundation Launch: New Ways to Address Key Pharma Industry Needs
On 19 June, ISPE officially launched the ISPE Foundation. The philanthropic arm of ISPE "will enhance ISPE's ability to support its members and the pharmaceutical industry as they prepare to address new and evolving industry demands," according to Michael A. Arnold, ISPE Foundation Board Chair, and John E. Bournas, ISPE CEO and President.
Message from the Chair - A Year of Achievements
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A Year of Achievements
I write my final "Message from the Chair" article full of a range of thoughts and emotions. Perhaps the best way to sum up my feelings is just to say, "Time flies when you're having fun."
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More Advice from the Top
My conversation with six members of ISPE's Board of Directors continues this month.
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Time Flies: A Look Back—and Ahead
I am pleased to have another opportunity to share some thoughts and provide a quick update about the progress of ISPE. It is hard to fathom that we are halfway through 2018, and summer is upon us (at least those of us in the Northern Hemisphere). ISPE had a very busy first half of the year, with three major conferences in North America, a very successful Europe Annual Meeting in Rome, and...
Preparing the Workforce of the Future - Chalkboard
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Preparing the Workforce of the Future
In our industry, as in many others, the most important goal is developing and delivering a product that satisfies our customers. In our industry, the end customer is the patient.
Article
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Pairing Knowledge with Imagination
Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world. —Albert Einstein
Article
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First Quarter Update
Fellow members, it is my pleasure to provide a short update on some of ISPE's accomplishments, its strategic plan, and ongoing activities.
EMA Moves to Amsterdam
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European Medicines Agency (EMA) Moves to Amsterdam
The United Kingdom's (UK) "Brexit" vote to leave the European Union (EU) by March 2019 has created challenges for the European pharmaceutical industry. Among the first important decisions resulting from the impending departure was where to relocate the European Medicines Agency (EMA), currently headquartered in London. On 20 November 2017, the EU's European Council resolved this concern when...
Article
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Heroes Make Us Strong
A hero is someone who has given his or her life to something bigger than oneself. — "The Hero's Adventure," in 'The Power of Myth', by Joseph Campbell with Bill Moyers, 1988
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Acing the Photo Interview
Hi David, I've had a few phone interviews recently, but I never go any further in the process. What am I doing wrong?
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ISPE Strategic Plan Update
"Local and regional relevance" is a key component of our strategic plan, and one that is critical to our success as an organization. It pledges us to "understand and shape strategy to the business, culture, and regulatory issues of local and regional markets." Here are a few ways in which we are doing just that: