Medical Device Regulation - Article 117 Action Required
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Together Beyond COVID-19
To get answers to your COVID-19 questions, why not #AskTheExperts at PharmaLex?
We find ourselves in one of the most challenging situations in history. In a very short time, the world has been consumed by a virus that has proved to be both ruthless and deadly. Countries all over the world are battling an invisible enemy and yet remain resolute in the face of such adversity.
COVID-19 is evolving daily and represents an enormous challenge to public health, society and organizations seeking to maintain business operations. It is therefore imperative that we are able to react quickly and effectively. As a company we are closely monitoring the situation and have set-up a taskforce to recommend and communicate how we can take consistent approaches together to support our clients, protect our employees and our business during this pandemic. We see this as an opportunity to learn, grow, innovate and increase in flexibility. This is beyond corporate social responsibility, it’s way more – both as healthcare professionals and individuals. Our combined expertise can really make a difference and we are committed to going above and beyond to fight this as an industry.
However, despite the current crisis, product development continues and regulatory compliance, quality management and on-going pharmacovigilance must be maintained. It is important to also look beyond COVID-19 and have a strategy in place to manage this. Planning at a local level will help boost resources and ensure delivery plans are aligned when the time comes. Now is the opportunity to put in place fail-safe measures that will ensure business can continue now and will continue and grow when the crisis is over.
It is in times such as these that we can ensure that we work together. We are proud that we continue to support our clients and provide the necessary backbone which allows our industry to deliver.
Our approach is straightforward – we have experts across the globe who understand the current challenges and deliver solutions remotely. Our experts are available to answer your questions #AskTheExpert. Our IT infrastructure includes cloud-based technologies, and now more than ever, we see its value. Whilst on-site services are inevitably affected, our flexible team of committed experts is tailoring our solutions to your changing circumstances and has adopted a virtual approach wherever possible to deliver now and BEYONDCOVID19 – business continuity.
We remain dedicated to ensuring our clients can continue their vital work at a time when it is needed more than ever. Together Beyond COVID-19.
“How to mitigate manufacturing site closures?”
“What to do when clinical trials are closed / postponed?”
“How to manage interruptions or slow-down of business processes?”
“What are the alternatives to face-to-face audits?”
“Are frozen budgets affecting development strategy?”
“How to maintain legacy portfolios without necessary resource?”
“Getting a slower response from regulators?”
Related Resources
Highlighted services PharmaLex can provide virtually during COVID-19
The outbreak of COVID-19 has resulted in the requirement for the majority of personnel in technical companies to work remotely. The situation is evolving globally, and pragmatic actions are required to deal with the challenges faced by companies who need to conduct business and maintain compliance while also ensuring the safety and wellbeing of all personnel. As a result, companies are making contingency plans in preparation for the spread of COVID- 19 to ensure business continuity during this time.
Most recently for example, the European Medicines Agency (EMA) and US Federal Drug Administration (FDA) have updated guidance on the management of clinical trials during the Coronavirus pandemic to allow services to be conducted remotely as an alternative to physical visits in order to mitigate the risk posed by the COVID-19 pandemic on the conduct of clinical trials. Further information is available at the following link:
https://www.fda.gov/media/136238/download
As on-site visits to client facilities are generally not permitted during this time, a contingency plan in line with the updated EMA guidance has also been adopted by PharmaLex to support our clients during this difficult time.
PharmaLex are well placed to offer consultancy services in the current climate and have an extensive global network of personnel located in offices in over 21 countries who understand the current challenges faced by clients and in response are ready to deliver solutions remotely as follows:
Our experts will be available to answer your questions on the PharmaLex webpage using #AskTheExpert.
Our secure IT infrastructure includes cloud-based technologies, and now more than ever we see its value. Our flexible team of experts have adopted a virtual approach wherever possible to deliver now and beyond COVID-19 to ensure business continuity.
Below are a range of services PharmaLex can provide remotely during COVID-19, including and not limited to:
- Provide advice on short-, mid- and long-term strategies resulting from the current situation
- Help get an overview on the working-status of Health authorities worldwide and help mitigate in situations where agencies are unable to work at capacity or even not reachable
- Can act quickly, if you are facing shortages in Regulatory affairs personnel
- Help define second-supplier-strategies for APIs, other excipients and drug product production (resulting for example in site transfers of APIs from China/India to Europe)
- Provide strategies on protocol deviations and amendments in relation to COVID-19
- Has a global team to support in submitting formal amendments or supplements for trials in the respective countries or areas
- Can foster the process to implement strategies for applying accelerated approvals by authorities and ethic committees
- Conduct workshops relating to a wide range of development quality compliance and regulatory topics to determine the scope of work and to develop a work plan or road map outlining the specific deliverables that will allow us to meet your requirements
- Virtual workshops can now be conducted remotely through virtual conferencing and virtual meeting software capability which allows team members to brainstorm ideas, exchange feedback and remain focused on the task in-hand
- Can develop Quality Management System documentation for clients remotely as follows:
- Conduct a workshop or teleconference meeting with the client remotely to understand their business model and regulatory obligations
- Develop the required documentation such as SOPs, Policies, Quality Agreements, Quality Manual, Site Master File, Protocols and Reports and work with the client to ensure a seamless transfer of documents from PharmaLex to the client
- Regular team meetings with the client using the latest software tools for communication to provide an up to-date status of the work
- Can provide contract staff for the above listed roles that can work remotely for the client
In the life science and pharmaceutical industry, audits are necessary to comply with regulations and to ensure the quality of products. The understanding is that if manufacturing is continuing, so should a meaningful program of audits. Fortunately, PharmaLex offers ‘virtual audits’, thereby conducting an audit without being physically present at the auditees facility as follows:
Conduct a Risk Assessment to determine the urgency and requirement to conduct the audit.
- If following this assessment, it is deemed necessary to conduct the audit, the following Virtual Audit activities are recommended:
- Perform a desktop audit by providing a detailed audit questionnaire to the auditee containing a list of relevant questions and requesting pertinent site documents
- A remote audit can be conducted by virtual conference with the client and utilising screen sharing software to share any media securely on your device without the need to transmit proprietary files e.g. presentations, images and even videos
- If possible, conduct a tour of the facility virtually using site layout drawings, approved photos or videos that are presented by the SME on the conference call
- Provide the audit report and support the client and auditee with closure of any actions outline in the audit report
The outbreak of COVID-19 has also forced a delay of the MDR application from the 26th May 2020 by one year to May 2021.
- Further information on the European Commission’s announcement can be found here.
PharmaLex leverages over 20 years of Medical Device expertise with experts in this field that can provide the required support remotely to ensure the client meets this international regulation. The below page provides further information on the activities PharmaLex can provide remotely to meet this deadline:
If you would like advice or support in relation to the services PharmaLex can provide remotely during COVID-19 please get in touch to find out more on the range of services that we offer and how we can help you by connecting with us by email at contact@pharmalex.com.
Our client commitment
In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.
Thomas Dobmeyer, CEO PharmaLex
CEO PharmaLex
CEO PharmaLex