PSI VisSIG Wonderful Wednesday Webinar Series
This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.
The purpose of the regulatory SIG is to co-ordinate regulatory activities across the European Pharmaceutical Statistical community and to engage with Regulatory statisticians.
• Review of regulatory guidelines and policies to provide consolidated cross industry responses
• Identification of regulatory statistical issues that are concern across industry for discussion with regulators.
• Regular engagement on statistical issues with statisticians at EMA Biostats Working Party and MHRA
• Promotion of best practice and driving debate on future guidelines
|Lars Endahl Laen||Novo Nordisk||Denmark|
|Mette Krog Josiassen||Lundbeck||Denmark|
|Frances Lynn||independent consultant||UK|
|Anja von Heydebreeck||Merck||Germany|
We have been meeting annually with the MHRA statisticians for an informal exchange of statistical topics important for both regulators and industry since at least 2007. Our most recent meetings were:
Since 2013 we have also been meeting annually with the statisticians of the EMA Biostatistics Working Party for a similar exchange of statistical topics important for both regulators and industry. The meeting held virtually on 2 October 2020 used a different format, as it was held jointly with other stakeholder organisations (which included EFPIA, AESGP, EGGVP, EUROPABIO, Animal Health Europe, Medicines for Europe and EUCOPE). The discussion focused on the impact of COVID-19 on methodological aspects of on-going clinical trials and statistical methods applied to the quality of medicines, and minutes from the meeting can be found here. Using a similar format, another meeting with several other statistical stakeholder organisations was held on 29 October 2021. This time the exchange focused on two topics only (raw data submissions and use of external control data) and therefore was better suited to an exchange of information than the previous year. Minutes from the meeting can be found here.
One of the key activities is the review and collating of comments on key statistical documents, which included the following:
Several SIG members have helped to organize the EFSPI workshop on Regulatory Statistics every year. The most recent event was held virtually from 13th to 15th September 2021, focusing on decentralized trials, complex innovative designs and Real World Data.
On 21 October 2021 the PSI/EFSPI Regulatory SIG jointly organised together with the American Statistical Association Biopharmaceutical Section (ASA BIOP) a webinar on Complex Innovative Designs, which covered the following aspects:
The speakers were John Scott (FDA), Dieter Häring and Marius Thomas (Novartis) and Olivier Collignon (GSK), which was followed by a panel discussion chaired by Jürgen Hummel (PPD). A video recording of the event and presentations can be found here.
On 5 November 2020 the PSI/EFSPI Regulatory SIG jointly organised together with the American Statistical Association Biopharmaceutical Section (ASA BIOP) a webinar on Estimands, which covered the following aspects:
The speakers were John Scott (FDA), Andreas Brandt (BfArM), Evgeny Degtyarev (Novartis) and Vladimir Dragalin (JNJ), which was followed by a panel discussion chaired by Anna Berglind (AstraZeneca). A video recording of the event and presentations can be found here.
On 4 July 2019, the PSI/EFSPI Regulatory SIG organized the webinar on ‘Adaptive design: updated draft FDA guidance and its implications’. In the webinar Jürgen Hummel (PPD) shared an overview of the FDA’s updated guidance on adaptive design for clinical trials of drugs and biologics, and discussed implications for industry. This was followed by the introduction of an open-source statistical software for adaptive designs, RPACT (an R package available on CRAN that enables the design and analysis of confirmatory adaptive clinical trials) led by Kaspar Rufibach (Roche). Kit Roes (Working Group Methodology of the Dutch Medicines Evaluation Board and member of the EMA Biostatistics Working Party) closed the webinar by commenting on the guidance from a European Regulatory perspective.