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Regulatory Focus™ > News Articles > 2020 > 5 > Outsourcing in regulatory operations

Outsourcing in regulatory operations

Posted 07 May 2020 | By Jen Multari, MSc, RAC 

Outsourcing in regulatory operations

This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities.

Introduction

The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that time, regulatory affairs was decentralized and following compartmentalized approaches to health authority (HA) submissions and interactions. Global regulatory affairs (GRA) distributed the needed core documents and an EU-based “Master Dossier” to the local countries and regional operating units (R/OPUs). Local regulatory affairs (LRA) colleagues would then complete the local documentation and submit a dossier based on local HA requirements and standards, which led to a loss in corporate oversight. Submitted quality-relevant documents, as well as approved registrations, were tracked within a corporate regulatory information management (RIM) database, but corporate itself had little insight into the full submission package or any subsequent interactions with the local HA. As a result, corporate was unable to quickly and reliably present what information was submitted to a HA. Additionally, it was discovered that LRAs were modifying documents provided by corporate but doing so without informing GRA. This led to a potentially significant compliance risk for the company.
 
In early 2015, to address the situation, the author, a team leader in the global regulatory operations (GRO) group, would implement a large-scale, global project to critically map, understand and evaluate the current local compilation process and define and implement appropriate measures to improve quality, transparency and efficiency in a to-be-defined process. The aim of the project was to centralize all technical tasks associated with dossier compilation and submission within outsourced global vendor “hubs” to deliver the expected improvements and minimize the regulatory compliance risk.

Project BRIDGE

Project BRIDGE (Building Regulatory Improvements, Driving Global Efficiency) was designed to centralize processes and services, including dossier planning, compilation and publishing, submission, tracking and archiving, to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities.
 
The assembled project team consisted of a mix of GRA functions, including LRA and members of GRO. In addition to actively working on project deliverables, the team represented their respective functions and provided open communication both into and from their organization. As project lead, the author created and maintained the project plan, oversaw operational responsibility for the progress of the project and delivery of results, controlled the project schedule and resource needs and actively communicated with all stakeholders. Figure 1 outlines the four phases of the project.
 
Multari-Figure-1-(1).PNG
Figure 1. Project approach in four phases

The purpose of Phase I was to perform a thorough as-is analysis to understand the current situation, collect data to support the initial thinking that led to the creation of the project and provide a baseline to compare current and future process performance. This stage lasted from approximately April 2015 through June 2015.
 
Phase II focused on design and piloting future process to verify quality and effectiveness of the defined measures. In conjunction with process creation and piloting, workshops took place with the selected vendor to begin establishing hubs and hiring technically competent individuals in preparation for process implementation took place. Three hubs would be established globally—Bridgewater, New Jersey (US) to accommodate the Americas time zones; Gdansk, Poland to handle Europe, Africa and the Middle East and Singapore to work with the Asian-Pacific countries. An expansion of a fourth hub was already in place in Budapest, Hungary to handle only data entry into the corporate RIM database. This phase ran from July 2015 through December 2015. After presentation of the results of this phase, the steering committee agreed to move into the next phase of the project.
 
Phase III began in January 2016 with refinement of the piloted process, construction of a rollout plan, setup of systems, updates to corporate SOPs and creation of training material and a request system. This phase ran through March 2018 with the vendor hubs and countries onboarding into the new process in a rolling fashion.
 
Phase IV began after the first countries went live and is ongoing. Phase IV represents the shift from project status to an operationalized business-as-usual way of working. The purpose of this phase is to continually assess the stability of the process and make any of the changes and improvements sustainable.

Problem statement

As stated in the project charter from May 2015, “The key issues that the project is expected to improve… will be verified and quantified in Phase I of the project.” The following observations have been made by the organization:
  • Corporate is globally accountable for pharmaceutical product compliance but is currently unable to quickly and reliably present the information submitted to all global HAs. Therefore, it is in no position to efficiently retrieve, present, review or verify the information, which is the basis for the marketing authorization in every given country.
  • Country-specific local regulatory requirements are not always brought to the attention of corporate or are not clear from a content point of view, leading to delays in providing the local regulatory documentation.
  • Occasional checks revealed that R/OPUs alter the content of the dossier by modifying documents without consistently informing corporate. This represents a potentially significant compliance risk for the company and may have implications for the global registration strategy.
  • Tracking of registered documentation in the corporate RIM database is sometimes inaccurate or entered late, leading to potential gaps in global oversight and governance.
  • Corporate estimates all resources involved in the dossier creation and submission process at the corporate level, as well as at the R/OPU level, are not optimally employed and that by centralizing key pieces of the process and services, it could be performed with fewer internal resources while delivering higher quality in shorter time.
  • As stated in the project charter, “Following the company’s strategy to deliver high-quality products to patients while maintaining competitive efficiency of the value-chain, the following goals have been defined for the project:
  • The current overall process performance will be understood, current key performance indicators (resource needs, process lead time, quality and quantity) defined and measured and the role of involved information technology (IT) tools and platforms made transparent.
  • The major process issues are identified and described.
  • Future process performance parameters are defined and agreed upon, considering future IT landscape.
  • The future centralized process is designed, its implementation planned and new and critical process parts executed in a pilot phase. The new process is fully embedded and stabilized within the global and local organization.
  • All related organizational units are accordingly set up and, if required, reorganized to fully support the newly defined process.
  • Activities that can be outsourced to cost-optimize the process while maintaining/improving quality and ensuring patent protection are identified and an outsourcing process defined.
  • Transparency on all local submissions in an archiving solution.

  Case Study Questions

  • Were the problem statements identified before the project began rectified and resolved?
  • What is the perception of GRA and LRA colleagues regarding the project and the established resulting change? 

Critical Review of the Project from the Business Perspective

In-Scope/Out-of-Scope

Project BRIDGE focused on the technical tasks associated with centralized dossier compilation. The process begins with planning the content of a submission package, followed by multiple steps and interactions between local and global functions, which results in a dossier or submission sequence, to be submitted to the HA. The process ends with archiving a copy of the submission package in the corporate RIM database. The project affected all GRA and LRA functions and only the company’s prescription medicine products were in scope. Figure 2 depicts the high-level process flow.

Multari-Figure-2-(2).PNG
Figure 2. High-level process flow
 
The project charter defined the following activities as out-of-scope:
  • processes related to the creation/authoring/archiving of submission-relevant documents in the company’s document management system (DMS)
  • quality improvements for submission relevant documents
  • other activities within the corporate RIM database, outside of the in-scope specifications

Key Performance Indicators 

The following are key performance indicators defined for the vendor hubs:
 
Category Metric Target
Quality Completeness according to content plan 100%
Quality Right/correct documents linked 100%
Quality Correct document version used 100%
Quality Document in right location of the country-specific dossier template 100%
Quality Leaf titles correct compared to TOC R: <98%
G: ≥98%
Quality Submission-level hyperlinking correct R: <98%
A: ≥98% and <99%
G: ≥99%
Quality Technical validation correct 100%
Quality Paper validation correct according to paper checklist R: <96%
A: ≥96% and <98%
G: ≥98%
Compliance Delivery in time, according to plan 100%
Compliance Completion of process in time, archiving according to timelines 100%
R, A, G = traffic light metrics (red, amber, green)

Project benefits

At the start of the project, the potential benefits outlined in the project charter were:
  • improved transparency over regulatory status of all products across all markets
  • increased overall quality and compliance of the submitted dossier according to local regulatory and corporate regulatory strategy requirements
  • shorter time to submission (depending on local strategy)
  • gained flexibility and scalability of the process due to outsourcing of certain high-volume tasks
  • reduction of total cost and resources for the full process

Project risks and mitigation

The project charter identified the following risks and subsequent mitigation measures:
 
Project Risk Mitigation Measure
Non-availability of key project contributors throughout the project leading to progress slowdown and delays
  • Reliable planning and project progress control
  • Management buy-in to the plan
Unclear, and thus changing, scope of the project leading to delays, poor quality of results
  • Well-designed project charter approved by management
  • Clear and close communication with steering committee
Conflicting interests between various parts of the organization (e.g., corporate, LRAs)
  • Involvement of concerned stakeholders
  • Clear management mandate
  • Well-designed change management support
Lack of commitment to introduce the results
  • Clear management mandate for the entire global regulatory organization
 

Additional information

Rollout of the new process to all countries began in April 2016 and ended in March 2018. The rollout consisted of five key phases:
 
Phase Definition
Country-Specific Workstream
  • A local process coordinator (LPC) was defined by the LRA for each country.
  • Two months prior to go-live, a corporate process coordinator (CPC) would contact the LPC and establish meetings.
  • The LPC would complete a questionnaire with country-specific information to help ensure a successful connection to the BRIDGE process.
  • If country-specific templates were needed, these would be created and implemented within publishing systems at corporate.
Training
  • Online training covering new process and request system would be completed for all LRA members of that country.
  • Mock work would take place two weeks prior to go-live to give LRA an opportunity to experience the BRIDGE process and use new tools.
Go-Live
  • Three months from the start for that country workstream, the country would be live and begin using the new tools and process for their submissions.
Hypercare
  • A six-month period following go-live when the CPC would be available to questions or concerns directly.
Business-as-Usual
  • Following hypercare, the LRA addresses all questions to a general inbox instead of an individual.
  • The process and tools have been successfully embedded into the day-to-day process at the LRA site.
 

LRA survey 

In early 2018, the author sent a survey (below) to the LRA colleagues responsible for the 148 active registration countries affected by Project BRIDGE. The questions were developed after reviewing the following resources on implementation of large-scale change.1-3
 
Proposed Questions Answers
Q1: For how long has your country been live with the BRIDGE process?
 
Q2: How many submissions from your country have used the BRIDGE process to-date?
Provide date and number ranges instead of a free text box, to assist with anonymity.
Q3: Were the vision and objectives for this project clear and specific?
 
Q4: Do you feel the change driven by BRIDGE will help your country/region more easily adapt to future technical regulatory requirements?
 
Q5: Do you feel the project was needed at this time?
 
Q6: Do you feel GRA management effectively guided this process?
 
Q7: Did you have the appropriate channels to provide feedback, requirements, and/or input into the BRIDGE program?
 
Q8: Given the timelines put into place, including the country-specific collaboration, training, go-live and hypercare, do you feel you had sufficient time to implement these changes?
 
Q9: Do you feel there is, or has been, enough support by GRA management and the BRIDGE project team throughout the process?
 
Q10: Do you feel the project generated the right tools or instructions to get the job done?
 
Q11: Do you feel the process is sufficiently implemented to become routine and part of your daily work?
 
Q12: Do you feel project progress has been adequately publicized?
Range from Strongly Agree (1) to Strongly Disagree (5)
 
There were 110 unique and anonymous responses to each question. The majority of responders also included a comment in the free text field for each question. The results of all questions are in Figures 3 and 4 below. The critical analysis below evaluates the answers and comments on questions 3 through 12.

Multari-Figure-3.PNG 
Figure 3. Average response across all questions with 95% confidence values. 1=Strongly Agree, 3=Neutral, 5=Strongly Disagree
 
Multari-Figure-4.PNG
Figure 4. Frequency of responses across all questions. 1=Strongly Agree, 3=Neutral, 5=Strongly Disagree
 

Discussion and results

Please note: the author has edited some LRA comments in the discussion points for grammar and brevity.

Question 3

Since the start of the project, GRA management and the author were actively publicizing the vision statement for the project. The vision statement and objectives were reviewed during the rollout meetings with the countries, at any meeting where BRIDGE was a topic, and it was clearly stated in documentation and the BRIDGE intranet site.
 
Even with all this publicity, the topic of efficiency or timesaving was often added in by the LRA as an objective for the project. As stated above, the vision was clearly to improve compliance, transparency and quality. GRA management attempted to combat this at multiple time points by repeatedly stating the project’s objectives did not include saving time or headcount, but the comments in the LRA- responses focused on these items.
 
Selected comments from LRA:
  • Objective was to increase transparency and increase efficiencies; however, efficiencies at a local level have decreased as it now takes much longer to achieve an output/submission to the HA.
  • Although quality and standardization were clearly presented as the objectives of the project, some people thought it also would be a gain in time, which is not the case.
  • The processes for HA submission-package preparation, including initial submission and response, became complicated and time-consuming. 
The author feels, in hindsight, more could have been done to get the message across. At the time, the level of communication felt right. As the project is already operationalized, the team today is focusing on ways to improve the process, with the feedback and help from LRA. The new processes are becoming more accepted, especially as the team continually implements improvements. The author believes the collaboration with the countries can only get better as time goes on.

Question 4 

HA technical requirements for submissions are changing frequently in recent times. Organizations need to be fast-paced and agile when it comes to understanding and implementing these new requirements. Some examples are the electronic common technical document (eCTD) in China,4 mandatory eCTD requirements in Canada,5 the substance, product, organization and referential (SPOR) data management initiative in the European Union6 and the International Council on Harmonisation (ICH) eCTD 4.0 implementation.7 These examples are a small sample of an ever-changing field as requirements constantly race to meet the opportunities of new technologies.
 
A focus of Project BRIDGE was to help alleviate the burden faced, or to be faced, by the countries during the introduction of these new requirements. LRA is still obliged to understand the initiatives and their impact on submissions, but they no longer need to be alone in implementation. The colleagues at corporate are now responsible for understanding the requirements from a technical perspective, creating new processes with the vendor where needed, confirming with the country colleagues that the output matches the requirements and lastly implementing the requirements.
 
Selected comments from LRA:
 
Other pharmaceutical companies already started to use hubs similar to BRIDGE, as it works well for regulatory teams when a hub takes care of publishing work for submissions. This is an excellent approach for us to finally do this.
  • In the future, yes.
  • Yes, because once we move completely to eCTD, we will no longer be able to compile dossiers locally anyway.
  • It depends on the scope of the new technical requirements. For something like (ICH) eCTD v4, I do think that centralizing publishing would make it easier to adapt to this change, but when it comes to region-specific changes, such as HA pilot projects, I don't see much of a benefit.
  • As project lead for this initiative, the author’s takeaway from these comments was that corporate needs to spend more time engaging with the countries on a personal level to ensure corporate
  • more fully understands their requirements for the future
  • better explain the technical capabilities of the systems
The publishing tool is flexible and the corporate colleagues who serve as process managers and key users are able to quickly adapt it to fit any new technical requirements. It appears there is a need to better demonstrate this to LRA. The BRIDGE team continues to look for ways to improve the process and remove burden from LRA.

Question 5

As discussed previously, corporate was adamant a project like BRIDGE was needed immediately, but most countries disagreed. At the time, there were many comments that they felt “punished” because of the inappropriate actions of a few. While the driver for BRIDGE was certainly because of a lack of transparency and quality within a few key countries, the benefit to corporate to implement such a project was enormous, and management felt this outweighed the backlash and negativity. As a result, the responses to Q5 were mainly negative.
 
Selected comments from LRA:
  • For countries that were not able to do their own publishing/compiling this could be seen as being beneficial. However, for countries that already had established a process, this project introduced many additional levels of complexities.
  • It makes sense to centralize the process; however, it did not create efficiency for submission preparation. The BRIDGE process has affected our timelines for submission preparation.
  • I feel this project should have been rolled out for regions where compilation support was needed.
 
Because of these comments, and further discussion with the countries, the project team has implemented a number of improvements, all of which have been met with very positive feedback. When receiving a dispatch with the error-detecting code, cyclic redundancy check (CRC), the countries now have a link to download the entire package rather than having to download individual documents from the document management system. Additionally, a step was removed from the overall process, leading to less email traffic. Additional room-for-improvement process changes are currently under way, and the team feels these will also have an impact on the work performed by the LRA.

Question 6 

As previously discussed, GRA management was the driver and enforcer of this project. As project lead, the author felt she had the unwavering support of the head of GRA, as well as his peers in human resources, the legal department and the countries. The author’s supervisor at the time ensured a path for success by removing obstacles such as budget restrictions or narrow thinking in terms of vendor setup. However, the question focused on the LRA’s perspective. The answers given mainly concentrated on their experiences with the rollout and implementation in their country.
 
Selected comments from LRA:
  • GRA and other colleagues are always helpful when questions are raised.
  • The gap between training and the go-live date per country was too long. By the time regulatory colleagues needed to apply the trainings, the info was forgotten. The local project coordinators got plenty of attention and assistance and performed local re-trainings. The BRIDGE homepage also has a lot of useful information resources.
  • Effectiveness does not depend only on guidance provided, but also on the chance LRA must follow the new process (currently only for national procedures). A regular refresh training would be highly appreciated.
  • I feel that GRA managed the project well.
  • I think again that many sessions per OPU should have been set to guide the LRA on this process. 
As rollout of the process occurred, it quickly became evident to the project team the LRA did not always submit something through BRIDGE right away, leading to training retention issues. The team has since recorded the training sessions so that they are available on-demand and also has instituted monthly Q&A sessions for the countries to ask questions, have small refresher trainings and work through issues. Additionally, one-on-one refresher training sessions were offered to countries struggling with the process. A central mailbox for questions is in use and monitored by colleagues at corporate. Members of the project team also have a dedicated time slot at the monthly GRA/LRA calls, to discuss topics of importance for the LRAs. It is clear, in the author’s opinion, the support provided by corporate has increasingly improved and will continue to do so during operationalization.

Question 7 

As described earlier, the CPC and LPC setup allowed for frequent interaction and discussion between corporate and the countries. The author was convinced this would generate a positive response to the project and its implementation in each country. In addition, the interaction would give a clear path for providing feedback and discussing requirements.
 
Selected comments from LRA:
  • Yes, the point of contact and communication was available.
  • Generally, we have found the GRA contacts to be helpful.
  • Yes, the BRIDGE GRA mailbox and the frequent Q&A sessions have allowed for effective feedback regarding specific BRIDGE steps/processes. Individual members of the BRIDGE team were also responsive and willing to hold discussions regarding.
  • The regional centre's contact person and global contact person gave appropriate support.
  • Not clear what channels are available to provide feedback. 
To ensure feedback was addressed following the survey, the project team has met more frequently, implemented process changes and done an overall better job advertising the changes in a “you asked, we listened” manner. The LRAs appreciate this approach.

Question 8 

The project team created the multistage approach for rollout and implementation to have time to address the questions and needs of the countries. Approximately halfway through rollout, the team created on-demand training sessions instead of holding four virtual, instructor-led training meetings per month. The workload at that point was at its threshold for the small group of CPCs, and the recorded training sessions freed their time to focus on rolling out too many countries at once. Unfortunately, the recorded sessions did not always meet the needs of the countries, resulting in follow-up from the CPC in most cases. The responses below reflect this.
 
Selected comments from LRA:
  • The online training instead of classroom training was not effective.
  • Training was a bit too early compared to go-live date.
  • Time was sufficient, but training could be improved.
  • The training was done too early and did not include day-to-day details of the process.
  • It would be useful if we had trained more than one scenario.
  • The training and Q&A session via online methods was not effective to implement these changes. 
As discussed previously, the project team has considered these comments and updated, again, the training concept. While online training is still required, the team offers personalized virtual or in-person, if invited and feasible, training sessions.

Question 9 

The LRA expressed concern about lack of process knowledge and struggling with the rollout. The author believes the previously described changes introduced following the survey will help alleviate some of these issues.
 
Selected comments from LRA:
  • The team is always available for our queries to provide us the required support.
  • GRA and the BRIDGE project team have been supportive during the process and are open to suggestions. We have had many discussions with the members of the project team regarding local processes and impact. I do think that regular updates and communications about the progress of the project and any troubleshooting that is occurring would be helpful.
  • I do not think we had enough support. We learned the process through practice and still some things are not clear yet. 
With BRIDGE, there were multiple opportunities built into the creation and implementation plans whereby short-term wins and successes could be celebrated. Usually, these took the form of an update during a global meeting, as described previously. Providing an update in a public forum allowed for recognition of the team’s -work to-date and provided an opportunity to discuss successes at the vendor hub and countries, for example. Additionally, during the implementation phase, a monthly email was distributed to global colleagues as countries were onboarded with BRIDGE, to acknowledge the on-going and successful rollout.

Question 10 

The project, like any project, has generated a large amount of documentation and information. At the beginning of the project, this information was unfortunately scattered across intranet sites and other databases. As the project team increased and more countries were included, an effort was made to collect everything in a central location that was easily accessible by the users. This resulted in a consolidation of documentation as well. Today, there is a single best-practice guide for the LRA, which has received positive feedback. Changes like this have a high impact to sustaining acceleration.
 
Selected comments from LRA:
  • Many tools are available and easily accessible. Instructions are very complete.
  • Process has many email templates, which seems too formal.
  • Team has commented that it is not fully comprehensive or intuitive. Only by actually working through a few submissions does the process become clearer. 
The BRIDGE process was initially designed as a one-size-fits-most concept, with the understanding that tweaks to the process would happen as more countries were onboarded. The BRIDGE team continues to meet on a weekly basis to discuss feedback from the countries and vendor and create impactful change to the daily work where possible. Changes to the process are in an FAQ document, for example, and a quarterly newsletter was distributed globally to ensure the successful story continues to be publicized. Through each of these initiatives, the effectiveness of the change is reinforced and barriers to resistance are removed.

Question 11

At the time the survey was distributed, most countries had been live with the BRIDGE process for six to nine months. As each country worked with the process more frequently, their understanding of the systems and tools would therefore increase and help solidify the change into their daily routines.
 
Selected comments from LRA:
  • Yes, the process steps are well established to carry out the new outsourcing compilation model.
  • It is difficult to do as a routine as we have only very few submissions in national procedure. It will come, however.
  • We have adapted to the process and are making it work. 
Project BRIDGE first began at the author’s company in 2015, with early adoption of a new language into the GRA/LRA culture—centralization, DMS usage, standardization, transparency, etc. In the time since implementation began and has concluded, the organization understands the process is the new way of life for submission creation and management globally. The training and pre-requisites needed for the process are part of onboarding procedures in the organization, and management enforces adherence to the process globally and locally. The change is sufficiently embedded within the regulatory organization, with the understanding that the process can be modified to meet evolving needs, technology and systems or constraints at the vendor. Sustaining the change going forward will continue to require a proactive approach, ensuring that, should management and people move on from their current roles, new employees understand and continue to integrate the process in their daily work.

Question 12

Prior to asking this question, the author could already anticipate the answers—which did not disappoint. The project team acknowledged that additional publicity was needed after rollout in all countries. Therefore, the measures described previously were implemented. Continuing in this manner has ensured more positive feedback and acceptance as implementations of the changes throughout GRA continues.
 
Selected comments from LRA:
  • The transparency of the project is not fully apparent to me. I would have liked to see a Q&A document in place so I could have learned from other regions’ issues.
  • We have heard little about overall progress or perhaps about any changes that have been implemented.

Conclusions and Recommendations

Assumption of perfection cannot occur with any project, and especially a project of the size and magnitude of BRIDGE. There were, and continue to be, challenges with acceptance, process adherence and perceived benefit to the LRA.
 
Reflecting on the initial benefits predicted by the project and the status of the project based on March 2018 survey results, it is clear the journey to meet these criteria has a way to go. As a reminder, the benefits were:
  • improved transparency over regulatory status of all products across all markets increased overall quality and compliance of the submitted dossier according to local regulatory and corporate regulatory strategy requirements
  • shorter time to submission (depending on local strategy)
  • improved flexibility and scalability of the process due to outsourcing of certain high-volume tasks
  • reduction of total cost and resources for the full process 
At corporate, it has become clear the transparency achieved in a post-BRIDGE world is better than it was previously and, thus, appreciated. Submissions are easily retrievable, and metrics surrounding global submissions are readily available.
 
Regarding shorter time to submission, flexibility and scalability, the team will investigate implementing a “follow-the-sun” approach to publishing in 2020. As one hub ends for the day, the next will pick up work on large submissions, distributing the work across multiple locations. With smart implementation practice, the anticipated benefit for this will meet these initial criteria.8,9
Even with these numerous challenges, past and future, the project itself has been successful. Rollout to 148 countries, setting up a new vendor model and ongoing management support, should not be taken lightly. The coordination, creativity and agility needed to get a project like BRIDGE off the ground has been remarkable.
 
The author would recommend that anyone embarking on a project of similar size and scope (perhaps for any size project) should use a trusted change management model, such as the 8-Step Process for Leading Change by Dr. John Kotter.10 The framework of the Kotter model allows individuals to drive change in a controlled and systematic manner. Identification of challenges and other obstacles occurs early in the project initiation, allowing project leaders to work methodically and efficiently with their teams, and is invaluable when it comes to ensuring buy-in from large groups. Even though the author and project team intuitively employ many of the methods described by Kotter, it would have been beneficial to have had the model built into the project.

References 

  1. Auguste J. 2013. “Applying Kotter’s 8-step process for leading change to the digital transformation of an orthopedic surgical practice group in Toronto, Canada.” J Health Med Informat. 4(3). https://www.hilarispublisher.com/open-access/applying-kotter-step-process-for-leading-change-to-digital-transformation-of-an-orthopedic-surgical-practice-2157-7420.1000129.pdf. Accessed 6 May 2020.
  2. Smith M E. 2003. “Changing an organisation’s culture: correlates of success and failure.” Leadership and Organization Development Journal. 24(5), pp.249-261. https://www.emerald.com/insight/content/doi/10.1108/01437730310485752/full/html. Accessed 6 May 2020.
  3. Richesin A L. 2011. “Assessing the Implementation of a non-profit organizational change initiative using Kotter’s (1995) 8-Step Change Model.” https://pdfs.semanticscholar.org/305c/4c6c476e9a8867daa9c029f680bd335d7130.pdf?_ga=2.39930337.214319510.1588869852-529626473.1588869852. Accessed 6 May 2020.
  4. Li L and Yang C. “The China Food and Drug Administration’s 2017 Reform Efforts Highlighted Seven Priorities.” Lexology website. https://www.lexology.com/library/detail.aspx?g=14ee20db-1e64-47bc-a7ab-a374c134a5e9. Accessed 6 May 2020.
  5. Mulero A. “Health Canada proposes mandatory eCTD requirements.” Regulatory Focus. May 2018. Regulatory Affairs Professional Society website. https://www.raps.org/news-and-articles/news-articles/2018/5/health-canada-proposes-mandatory-ectd-requirements. Accessed 6 May 2020.
  6. EMA 2018. EMA website. https://spor.ema.europa.eu/sporwi/. Accessed 6 May 2020.
  7. Brennan Z. “FDA offers new ICH guidance on organizing a CTD” Regulatory Focus. October 2017. Regulatory Affairs Professional Society website. https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/10/fda-offers-new-ich-guidance-on-organizing-a-ctd. Accessed 6 May 2020.
  8. Carmel E, Espinosa J A and Dubinsky Y. 2010. "Follow the sun" workflow in global software development.” Journal of Management Information Systems. 27(1), pp.17-38. https://www.tandfonline.com/doi/abs/10.2753/MIS0742-1222270102. Accessed 6 May 2020.
  9. Yap M. “Follow the sun: distributed extreme programming development.” In Agile Conference Proceedings (pp. 218-224). July 2005. IEEE. https://ieeexplore.ieee.org/document/1609825. Accessed 6 May 2020.
  10. Kotter J. “The 8-step process for leading change.” Kotter Inc. website. https://www.kotterinc.com/8-steps-process-for-leading-change/. Accessed 6 May 2020.
 About the Author
 
Jen Multari, MSc, RAC, is currently head of global publishing operations at Boehringer Ingelheim (Germany). She is responsible for the end-to-end processes around submission publishing, publishing processes and vendor management. Her experience includes director of regulatory operations at Mallinckrodt Pharmaceuticals and medical writing at Pfizer. Multari thrives on the topics of submission management and systems, process improvement and team transformation. She earned a Master of Science in European regulatory affairs from Danube University Krems. She can be reached at jen.multari@boehringer-ingelheim.com
 
Cite as: Multari J. “Outsourcing in regulatory operations.” Regulatory Focus. May 2020. Regulatory Affairs Professionals Society.
 

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