LifeBee is organizing a free webinar entitled: "Collaboration PPM for all pharma companies: why and how implementing a Next Generation PPM"

The path towards the introduction of Project & Portfolio Management in a company might turn out to be a quite bumpy road.

In our webinar we will drive you through the most common mistakes and seek to explain how to avoid them as to sustainably create an integrated PPM system for the various business functions, as we define it as a Next Generation PPM.

We will see what the value and benefits of the new generation platforms are, based on the concept of "Collaborative PPM" and we will hear directly from the customer voice how you can (and must ...) proceed step by step according to the growth of company maturity.

Who can't miss from Life Sciences?

R&D, IT, Engineering, Management and Purchasing.

AGENDA

11:00 Welcome & Introduction

Elvis Graffeo, LifeBee

Partner & Industrial Operations BU Director

11:05 Introduction: why is PPM essential?

Alessandro Raffone, LifeBee

Associate Manager BU Project and Portfolio Management

11:20 Next Generation PPM

Rupert Stuffer, Collaboration Factory

CEO

11:35 The experience of an Italian multinational Pharma company

Antonello Fazio, Angelini

R&D Budget, Contracts & Funded Project Manager

11:45 Q&A e Conclusions

Questions can be asked live during the webinar or anticipated during registration.

When?

Tuesday, October 25, 2022 from 11:00 a.m. to 12:00 p.m.

Free registration here

The webinar is for life science end users only, so LifeBee reserves the right to evaluate each registration and give subsequent feedback.

The ISPE International Board of Directors 2022 Election has concluded and the results are in and we are proud to announce the re-election of our Founder & CEO Teresa Minero to serve on the 2022-2023 ISPE International Board of Directors.

Our warmest congratulations go to all pharmaceutical leaders who have been elected to serve ISPE for the next two years.

Explore the dedicated ISPE webpage to meet this amazing team here

Yes, you heard it right, we are hiring!

LifeBee keeps growing and we are now hiring for multiple positions, check out our latest job openings:

2 Project Manager more info here

1 Principal Consultant more info here

6 Senior Consultant more info here

2 Consultant more info here

1 Service Desk more info here

To find out more about LifeBee, check out our Life Page

Don’t miss the opportunity to be part of our journey, join the team!

Mirka Broccato,
QP & GMP compliance Executive Consultant

Follow me on Linkedin

Read the first part here Document and data digitisation: an essential practice for conducting GxP Distant Assessment and Remote Inspection in Pharma.

Two years after the start of the COVID pandemic that disrupted not only our lives, but also our way of working, we have learned to juggle, more or less effectively, a thousand new challenges and opportunities for change.

GMP requirements and common surveillance practices that had been established for decades and with which we had become accustomed to dealing have been strongly impacted, and have forced all players in the Life Science world to change their working methods. The same regulatory authorities have been forced to deal with the critical issues related to the impossibility of travelling and reaching the sites to be inspected, and with the even more pressing need to exercise the fundamental role of surveillance essential to ensure public health.

After two years of remote inspections, ICMRA (International Coalition of Medicines Regulatory Authorities) and its COVID-19 working group (1) analyzed the experience gained with the new remote inspection approach and summarized their considerations in an interesting reflection paper.

The members of the ICMRA group all agree that, although remote inspections have been an important tool to carry out the surveillance necessary to ensure public health in the pandemic period, they cannot be considered as a complete substitute for on-site inspections.

The limits identified by inspectors in the execution of remote inspections refer to aspects linked to the relationship between inspector and inspected (e.g. inability to read non-verbal language that often allows to create the climate of trust necessary for the conduction of an effective inspection), inability to intercept structural anomalies or to verify in a rigorous way parts of machines or rooms with difficult access (technical areas, climatic chambers...) due to the limited visual field of the video cameras. Another obstacle to the effective conduct of remote audits was the extensive presence of paper documentation and the consequent difficulty and slowness in making it available.

The level of availability of relevant documentation was also taken into account as a factor that, along with others (such as complexity of activities, type of production -sterile, non-sterile...-, compliance history), determined the authorities' choice to proceed with a remote inspection rather than applying the traditional on-site approach.  Accessibility of electronic systems and access to original documents (e.g., SOPs, validation methods, process validation data, machine qualification data, participant medical records, signed informed consent forms, etc.) were seen as necessary factors for conducting an effective remote inspection.

The ICMRA working group found that the application and availability of the technologies needed to perform virtual facility tours (visual technologies & video streaming glasses) and to create platforms for sharing relevant GMP/GCP documents and information were key elements in the successful execution of remote inspections.

In the document prepared by the working group ((1) par 4.1.3), inspectors indicate how videoconferencing tools can also be used to review Data Integrity approaches through, for example, screen sharing of computer systems (a preferred option), data retrieval using a standalone computer, or review of exported audit trails. All of this can, of course, be applied as long as the entire process of making data available in GxP environments occurs under the supervision of Quality Assurance and that the computer systems remain in a validated state.

However, these types of inspections do not only involve the companies' Quality departments. The inspectors' experience has shown that the involvement of IT representatives from both sides in the early stages of logistics discussions and the execution of dry runs have been extremely beneficial, also in order to remove any obstacles related to the use of non-shared software, applications, transfer protocols that could have negatively affected the outcome of the inspection itself.

So, what can we expect in the future?

Some regulatory agencies are currently considering whether to use remote approaches in the future. There has been interest expressed by some inspectors in supplementing or replacing on-site inspection with remote inspection or hybrid approaches, e.g., to address a specific issue, contribute to an application assessment, or verify corrective/preventive actions that became necessary as a result of on-site inspections.

Therefore, after two years of remote inspections, what emerges from the inspectors' feedback is that, although with some limitations and circumscribing the scope of the inspection, the remote approach can be considered a useful tool to enable regulatory agencies to effectively exercise their oversight role in the future.

(*)  The working group was chaired by MHRA and had representatives from US-FDA, EMA, Health Canada, Swissmedic, HPRA Ireland, AEMPS Spain, ANSM France, PEI Germany, MHLW/PMDA Japan, TGA Australia, ANVISA Brazil, HSA Singapore, WHO, and Saudi-FDA.

(1)International Coalition of Medicines Regulatory Authorities (ICMRA) Covid-19 Working Group: Remote GCP and GMP Regulatory oversight inspections. Reflections on the regulatory experience of remote approaches to GCP and GMP regulatory oversight during the COVID-19 Pandemic

Our Founder & CEO Teresa Minero will lead the first session presenting the results of the 5th ISPE Pharma 4.0™ Survey, outlining the updates regarding maturity levels, adopted technologies, benefits and challenges.

Relevant subject matter experts will then discuss practical solutions and challenges from technical, managerial and regulatory perspectives. Participants will also have the opportunity to engage with industry leaders and peers in a 30’ virtual networking event.

LifeBee is always active in the Pharma 4.0™ debate and we are present also as a Sponsor.

Connect at 15:00 CET, complimentary registration here

Don’t miss it!

Teresa Minero was among the speakers of “Global Manufacturing and Industrialisation Summit 2021”, hosted in Dubai and co-chaired by United Nations Industrial Development Organisation - UNIDO.

Under the theme “Rewiring Societies: Repurposing Digitalisation for Prosperity”, this summit has convened global leaders and industry experts to discuss and debate the best ways to prepare for the post-pandemic recovery and determine the role of the industrial sector to accelerate this recovery.

During the panel “UNIDO and the Global Health Initiative: Utilising technology to enhance pandemic resilience” Teresa Minero has shared her own experience - as LifeBee and ISPE - in Life Science industry together with:

- Joshua Setipa - Managing Director, UN Technology Bank for the Least Developed Countries

- Amna Al Saleh - Ministry of Industry and Advanced Technology, UAE

- Bernardo Calzadilla Sarmiento - Managing Director, Directorate of Digitalization, Technology and Agri-Business, UNIDO

Great panel moderated by Declan Curry

Teresa’s takeaway: Why we must embrace digitalization in Pharma? To provide the right information at the right time and in the right place, to support decisions, more and more in a predictive manner to Operators, Managers till Authorities and Patients, to deliver safe, effective and innovative dugs at sustainable costs … in whichever country they may reside. Whether emerging or not”.

Teresa Minero opening the Panel Session on "Digitalisation of Pharmaceutical Industry" at the Eurasian ISPE Annual Conference with a speech "Where are we on Pharma 4.0™?"

Teresa: "It was an honour and a pleasure to be part today to the ISPE Eurasian conference in Moscow, even if virtually. Great opportunity to share the latest regulatory trends and how 4.0 in Pharma is playng a key role to be compliant".

Today Teresa Minero took part as Speaker, at the second Regional Conference on Industrial Development, under the theme “Acceleration of Industry 4.0 for inclusive and sustainable industralization”, organized by the Government of Indonesia in partnership with United Nations Industrial Development Organization - UNIDO.

It was a pleasure and an honor for LifeBee to attend this session and to share knowledge on Pharma 4.0 Industry!

Teresa Minero will open the conference "Advanced Processes in Pharma - Digitalization and Cultural Changes" organised by PEC - Parma Education Center, with a speech entitled "State of art in the Pharma 4.0™".

Digital transformation is affecting the entire product lifecycle, from R&D to product delivery to patient care.

The goal is to put patients and life quality at the heart of the pharmaceutical business.

When?

Thursday 14 October from 9:30 am

More info here

Registration here

We're beyond proud to announce that LifeBee has been awardered as "Most Innovative Digital Solutions Provider for Life Sciences" for 2021 in Italy, by the UK magazine AI Acquisition International.

A huge thank you to team who have worked incredibly hard to get us here.

Read the full article here (Issue 9 2021 - pages 14 and 15)