Career progression is rarely linear, and there is no single path to leadership. In our latest blog, Sinéad McKeon discusses what drove her move from the lab bench to project management. She reflects on the capabilities...
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Navigating regulatory landscapes: A guide to global submission standards
This blog summarises the key insights and recommendations from our recent webinar, offering a guide for pharmaceutical stakeholders navigating the complex terrain of regulatory submissions.
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Navigating CTIS: Setting up clinical trials under EU CTR
The EU CTR Nº 536/2014 came into force on 31 January 2022, repealing the Clinical Trials Directive and improving the harmonisation of clinical trials regulation throughout the EU and European Economic Area (EEA).
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Keeping up to date with the latest regulatory developments for decentralised clinical trials
This blog examines the crucial topic of regulating the use of DCTs, exploring what’s in place now and what sponsors need to consider as these methods continue to gain traction.
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The new EMA guideline expectations
In this blog, discover more about the new EMA guideline on computerised systems and electronic data in clinical trials.
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Medical device classifications and applicable Food and Drug Administration regulations
Medical device manufacturers should understand how their product is viewed by regulatory bodies to proceed with the appropriate regulatory pathway to market.
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MDR transition period and certification bottleneck
It is of paramount importance that companies with expiring certification begin the process to remain compliant under the new MDR. Read more about identified challenges and solutions.
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Advanced therapies for rare disease - a regulatory roadmap
Navigating advanced therapy development for rare diseases is challenging from many perspectives and requires a customised development strategy.
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EC proposes extended transition period for IVDR compliance
The European Commission has issued a proposal for a modified rollout of the new In Vitro Diagnostic Regulation (IVDR).
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Assessing the need for primary supporting clinical evidence or post-market clinical follow-up under MDR
Discover why identifying the study objective during the planning process for PMCF studies is a critical step in the transition to MDR.
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Risk, vigilance, and remediation under IVDR
The In Vitro Diagnostics Regulation (IVDR) will have a lasting impact on the entire in vitro diagnostics (IVD) lifecycle, from development through clinical investigations and regulatory approval.
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Managing COVID disruptions within IVDR timelines
The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.
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The impact of COVID-19 on pharmacovigilance
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
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Changes in clinical safety reporting to the FDA
FDA has upgraded the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies.
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EMA publishes second draft guideline on new MDR rules specifying quality requirements for drug-device combinations
Key takeaways from the EMA’s second draft guidance on MDR and its impact on combination products.
