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Together Beyond COVID-19
To get answers to your COVID-19 questions, why not #AskTheExperts at PharmaLex?
The development of a vaccine, from the lab bench to market readiness, is typically a very lengthy process and can take several years to complete. During a pandemic however, there are many initiatives in place to speed up this process. As an example, Health Authorities offer Conditional Marketing Authorizations (CMAs) and rolling reviews to substantially speed-up the time to authorize the vaccine.
How can companies act on these fast-track tools to develop COVID-19 vaccines? PharmaLex guides developers to establish a solid strategy around regulatory, safety, quality and manufacturing of their product. We currently support several companies with the development of COVID-19 vaccines and have extensive experience to guide our client’s novel medicines all the way through to marketing authorization.
Often product developments are taking place in parallel to accelerate market access. This can cause unforeseen challenges. There may be pressing questions to ensure product market readiness and quick scale-up to avoid manufacturing shortages to meet the COVID-19 vaccine demands. PharmaLex offers quick answers and flexible solutions to drive successful vaccine developments worldwide. We accelerate your product’s speed-to-revenue and help reduce risk by engaging our dedicated subject matter experts and utilizing our extensive understanding of regulatory health authority obligations and processes. Our goal is to ensure a smooth transition to market authorization whilst decreasing the risk of late-stage failure.
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 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.
“How to quickly scale up manufacturing sites to avoid shortages?”
“How to set up clinical trials for COVID-19?”
“How to develop a strategy for clinical trial applications for
COVID-19?”
“How to manage the rolling submission process for novel medications?”
“Getting a slower response from regulators?”
“Are frozen budgets affecting my development strategy?”
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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
Risk Assessment
- Facilitate or perform a pharma risk assessment to assess the risk to the supplier management program if the audit is delayed or postponed.
- If the risk of postponement is high, facilitate assessment of virtual audit feasibility.
Preparation for the Audit
- Agree the Audit Agenda with the client and auditee with particular emphasis on how the audit will be performed.
- Identify the appropriate technology for opening and closing meetings, sharing documents and discussing topics with SMEs.
- Identify the information that the auditors will require in advance for remote review.
- Develop a questionnaire for provision to the auditee to capture pertinent information in one location that will help set the scene for the audit e.g. organizational structure, certifications and facility description.
COVID-19 Pharma Virtual Audit
- Opening meeting through video conferencing.
- Auditing of the Quality Management System using documents that have been provided in the shared document repository and through conversations with SMEs over video conferencing platforms selected by the auditee or client.
- Virtual tour of the facility, if required, using cameras, virtual reality or alternative suitable methods.
- Feedback at the end of each day and closing meeting through video conferencing with all relevant stakeholders.
Reporting and CAPA
- PharmaLex will provide a written report detailing the observations made, classified according to risk and suggested remediation actions for each observation.
- PharmaLex can support with the implementation of Audit CAPAs.
- If required and recommended following the virtual audit, PharmaLex can support a follow up, on-site visit to the auditee when COVID-19 restrictions are lifted.
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:
COVID-19 patients
becomes effective
exemption
for use in COVID-19 patients
of required
change
Notification to EMA / NCA
EMA / NCA
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