Category Regulatory Updates

EPiC Auditors Autumn Compliance Seminar: Thursday 10th November 2022

Here’s what our speakers have to say about the pharma compliance event;

 “How to achieve Regulatory compliance for small, new and innovative companies can seem an impossible task. How to maintain pharma compliance for well established global companies can be equally challenging. We hope this seminar provides some useful advice and solutions for all pharmaceutical companies, whatever stage of maturity they are at. We look forward to delivering our second online conference and sharing our thoughts gained from our previous MHRA experiences, as well as from our recent projects within EPIC.”

Liz Allanson, EPiC Auditors Director and Senior Consultant

The transitional measures in place to support implementation of the Clinical Trials Regulation which replaces the Clinical Trials Directive are rather complex, and it can be confusing for clinical trial teams to know which sets of documents and requirements should be referred to depending on the location and legislation under which the clinical trial is conducted. This presents risks to compliance and a need for Sponsors to ensure that they have adaptable systems to cope with the flexibility of risk proportionate approaches proposed by MHRA, without overlooking trial specific or regulatory requirements for EU trials. At our Autumn Pharma Compliance Seminar, myself and Louise Mawer (ex MHRA Senior GCP Inspector) will be providing practical advice and real-world examples for Sponsors and clinical trials teams on key aspects of managing clinical trial activities during the legislative transitional phase.We will also be reflecting on the challenges for clinical trial supply chains following the UK’s exit from the EU, to help those involved in clinical trial supply understand the GMP expectations for IMPs, non-IMPs and QP certification requirements. The transitional implementation phase of the Clinical Trials Regulations has presented additional challenges at the IMP/GCP interface, and we hope our session will raise awareness of the different terminology and expectations to help maintain compliance with the changing requirements.

Michelle Yeomans, EPiC Auditors Operations Manager  

To find out more about the seminar and to book your tickets click on the link below:

With just over 3 weeks to go until the EPiC Autumn Pharma Compliance Seminar on Thursday 10^th November 2022 we have released a copy of the whole day’s agenda.

Here’s a summary of what is covered:

• Guest speaker Richard Parker, Senior GMDP Inspector at the MHRA will be delivering an MHRA update on Annex 1 with a regulators view of the changes.
• Richard Andrews (EPiC & ex MHRA GMP Inspector & Unit Manager) will be your host for the day as well as giving an overview of recent updates to guidance & regulations and how to future proof your compliance.
• Michelle Yeomans (EPiC Operations Manager and ex MHRA GMDP Inspectorate Unit Manager) will be reviewing the direction of travel for compliance and speaking to Louise Mawer (ex MHRA Inspector) about the implementation of the Clinical Trials Regulation and overcoming challenges at the IMP/GCP interface.
• Darren Jones (EPiC & ex MHRA Inspector) will explain how to develop your PQS and move from remediation to sustainable compliance, as well as discussing current and future Annex 1 deficiencies and the  the pitfall to avoid.
• Liz Allanson (EPiC & ex MHRA GMP Inspector) will give a presentation on points to consider when moving from an R&D to a GMP environment.
• Guest speakers Gaynor Brummitt (SeerPharma UK & ex MHRA Senior GDP Inspector) & Shahbaz Sarwar (SeerPharma UK ex MHRA GDP Inspector) will be explaining Importation and the Role of the RPi.       
• There will also be a Q&A session where a panel drawn from the speakers will answer questions submitted throughout the event.

Download the Agenda here:

The day promises to be of real interest to pharmaceutical industry professionals involved in the manufacture and supply of medicines and aims to;

• Share recent changes and updates to the GMP and GDP Guidelines and Regulations with particular focus on Annex 1.
• Highlight changes to inspection practices and MHRA oversight.
• Discuss tools and practices to maintain compliance.
• Present current and future Annex 1 deficiencies, along with the pitfalls to avoid.
• Provide insight into the changes arising from the implementation of the Clinical Trials Regulations and points to consider around the IMP / GCP Interface.
• Explore the challenges and considerations when moving from an R & D to a GMP Environment. 

How to secure your place

Tickets are now available to buy online and cost £250.00 + VAT

Click on the button below to register

Any booking enquiries, please email: enquiries@epic-auditors.com

In collaboration with SeerPharma UK

You may also be interested in the SeerPharma UK GDP Symposium taking place on Tuesday 8^th November 2022: Register and Pay Online Here

MHRA Inspectorate Blog has recently published Part 2 in the Compliance Monitor Process series with further information about the Compliance Monitor (CM) role and application process.

The blog can be found here: Compliance Monitor Process (Part 2)– CM role and application process

The blog acknowledges that it is common for companies that are at IAG to employ consultants to assist with remediation activities, and this is something that EPiC has extensive experience of supporting including reporting on progress to MHRA. The application process for an individual to apply for the CM pilot programme to be named on a register will be based on an eligibility assessment by MHRA considering career history, relevant experience, not having been personally the subject of MHRA regulatory action and/or significant adverse findings in the previous 3 years, and the need to have completed relevant training in the CM process. Eligible CM’s will then be assessed by MHRA for suitability on a case-by-case basis when they are nominated by a company, to confirm that they have sufficient experience of the dosage forms and site operations and that there is no conflict of interest. 

In response to the recent MHRA Inspectorate Blog post, Richard Andrews commented “It is good to see that both eligibility and suitability of the CM are being assessed which draws parallels from the naming of Qualified Persons (QPs) on UK manufacturing licences. Although a QPs eligibility to be named may be assessed by the Joint Professional Bodies, MHRA, or an EU regulator, their suitability to be named on a specific UK manufacturing licence is assessed and decided by MHRA based on site-specific knowledge and experience, which is above and beyond their eligibility assessment. The same two-stage approach will help to ensure CMs will have the background experience and site-specific knowledge to assess risks to product quality and patients in developing and overseeing remediation plans and assisting with implementation. This type of remediation work is a core service we offer at EPiC and is why our consultants will be applying to be named as CMs.”  

At EPiC, post-inspection remediation is a core element of our GXP compliance consultancy service. Many of EPiCs consultants have experience of MHRA Compliance Management team (CMT) and Inspection Action Group (IAG) processes, gained working within the MHRA and also outside as consultants. EPiC auditors regularly support companies who have been referred to CMT or IAG , leading root cause analysis workshops, advising on the response to the inspection findings, developing remediation plans and assisting with implementation. In a number of cases, EPiC have also provided assessment of compliance improvement following MIA suspension which have led to reinspection by MHRA and lifting of the suspension.

In response to the recent MHRA Inspectorate Blog post, which can be found here: Compliance Monitor process (Part 1) – An introduction

Richard Andrews commented ‘Based on our extensive experience to date, EPiC fully supports MHRA’s plan to further evolve it’s risk-based inspection practices with the launch of the compliance monitor process, which will see the MHRA begin a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors. EPiC intend to apply to be named on the register of compliance monitors and eagerly awaits the publication of the second part of MHRA’s compliance monitor process blog, which is expected to provide more details on the Compliance Monitor role and application process’.

We are very pleased to announce that Michelle Yeomans, GMDP Inspectorate Unit Manager at the MHRA will be delivering a Regulatory Update at the forthcoming GMP symposium.

Michelle will be covering the Clinical Trials Regulation and what it means to the UK, share the latest on the NI Protocol and the discussions with the EU, give an update on the transformation of the agency and highlight the top 10 deficiencies arising from GMP Inspections during 2021.

On receiving confirmation of Michelle’s participation Richard Andrews, EPIC Auditors Managing Director commented ‘we are extremely privileged to have somebody of Michelle’s standing and experience to present at the symposium. It offers a real opportunity for all delegates to receive the most current information on the changes facing the industry.’

This virtual pharma compliance conference will be a full day delivered remotely and is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as Qualified Persons, regulatory and compliance specialists involved in the manufacturing of medicines. 

The event will provide the latest information and guidance on changing legislation and give you insight into what you might have missed since the start of the pandemic. 

To find out more and to book your place follow the link here