Originally established in 1996 as the Biotech Working Party, the aim of the Biotechnology SPIN is to promote the development of realistic, common-sense and science-based approaches to the regulation of biological medicinal products by providing a sound understanding of the basic science and the available and emerging regulatory guidance via a focused education and training programme.
Its membership is made up of those who are involved in the full spectrum of applications of biotechnology and biologicals within the biopharmaceutical industry (recombinant proteins including biosimilars & monoclonal antibodies, vaccines and advanced therapies), all disciplines of regulatory affairs for these products (CMC, preclinical and clinical and regulators) and all sizes of company.
| Current activities |
Biotechnology SPIN Steering group |
- Organising several TOPRA courses, including Module 9 of the MSc in Regulatory Affairs
- Providing input to the TOPRA Annual Symposium
- Support and contributions to the publication of biotech-related articles in Regulatory Rapporteur
- ABC Biological (introductory level biological / ATMP webinars)
- Reg Rapp articles, May 2023
- Member Webinars
- Risk based approach to ATMPs
- Current development in ATMPs-Quality
- Clinical development of ATMPs
- Symposium session 2023
- Collaboration with other SPINS and MSc Modules
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We are looking to further expand our range by offering more frequent and informal opportunities to share and learn.
Those who join this SPIN are encouraged to contribute and can draw on the knowledge of the network’s members. As the network is there to serve the members, you can influence the development and format of the network and become actively involved with the activities of the SPIN Steering Group.
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The purpose of the Chemistry, Manufacturing and Controls (CMC) SPIN is to create a forum where TOPRA members working within Regulatory CMC functions across the globe, have an opportunity to share knowledge and experiences.
The SPIN steering group is made up of members with a range of backgrounds and experiences and covers a wide variety of drug modalities spanning small molecules, antisense oligonucleotides, synthetic peptides, proteins and ATMPs. The aim of the steering group is to provide a forum, allowing for cross-company sharing and collaboration and facilitates this by arranging regular webinars covering hot topics in Regulatory CMC, discussing the latest guidance, experience or trends and providing education opportunities for the TOPRA membership.
Any suggestions for topics for future webinars or expression of interest in becoming a steering group member are very welcome!
CMC Committee members:
Steve Wood
Gabriel Bohl
Angela Currie
Olivier Dirat
Peter Blakeney
Sarah Fitzgerald
Imke Veltman
Michal Mista
Anita Murray
Francisco Baptista
Julien Douillet
Marine Joly-Battaglini
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The purpose of the Combination Products SPIN is to create a forum where TOPRA members working with combination products across the pharmaceutical world and the medical device world have an opportunity to share knowledge and experiences.
The aim of this group is to organise monthly meetings that are a mixture of informal discussions, cases presented by the members, webinars presented by members, knowledge sharing from meetings, and presentations by guest speakers.
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The Clinical Trials SPIN was created to share information and experiences on the regulatory aspects of clinical trials.
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The aim of the MedTech SPIN is to exchange regulatory intelligence and experiences, particularly useful to those working in smaller companies.
Its activities include:
Technical input to the MSc in Medical Technologies Regulatory Affairs
The production of one-day training courses on medical technology topics, including those which are part of the CRED programme
Input on medical device topics to TOPRA’s Introductory Courses
Development of the Medical Devices programme of the TOPRA Symposium
Contribution to Regulatory Rapporteur
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The New Regulatory Professionals SPIN aims to provide information, discussion and networking for all those that are new to the profession and would like to know more about what Regulatory Affairs encompasses.
This SPIN serves as a forum within which members can exchange views, ask questions and seek information/advice, and as a space where useful resources and notifications can be shared with the SPIN community.
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The Patient Engagement SPIN is intended to be a source of best practice for applying patient engagement insights and learnings in the drug and medical devices development lifecycle.
The primary aims of the group are to:
To define a common understanding and definition of how Patient Engagement currently operates in the drug and medical devices development lifecycle and future opportunities for involvement across the life cycle
To provide a forum for members to share and build knowledge and ideas on ways to incorporate the patient voice early and consistently as a clinical program evolves
To promote the importance of patient engagement from a regulatory perspective
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The Pharmacovigilance SPIN was established in January 2009 to provide a forum for regulatory affairs professionals working in the field of pharmacovigilance.
The primary aims of the group are:
Raise the awareness of global pharmacovigilance in a European context
Promote collaboration between individuals and with other organisations involved in drug safety
Contribute to the raising of professional competency, standards and understanding of pharmacovigilance
Provide a forum for the exchange of information/knowledge transfer
Provide insights in and raise awareness of future developments
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The primary aims of the Product Information and Labelling SPIN are to:
Share regulatory knowledge and experiences related to product information across drug product life cycle
Provide training opportunities to less experienced members in the area of product information
Voice opinions via TOPRA to legislation consultations organized by regulatory agencies (EMA/MHRA/FDA)
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The RegOps SPIN was established to provide a vendor-neutral and independent source of collective information, advice and news on all aspects of regulatory operations for professionals from the pharma, biopharma, cosmetics, device and veterinary sectors.
The primary aims of the group are:
Educate TOPRA members on the developments in the regulatory operations landscape
Ensure that the needs of the regulatory operations sector are included in the TOPRA training programme and encourage expert input into course content
Encourage contributions to Regulatory Rapporteur
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The Regulatory Intelligence SPIN was established to provide a forum for members to share and build knowledge and ideas on Regulatory Intelligence, i.e. the act of collecting, analysing and using regulatory data from multiple sources to gain successful outcomes. This includes landscape of the current and evolving regulatory environment for opportunities and challenges to shape future guidance, regulations, legislation and policy.
The primary aims of the group are to:
To organise meetings, webinars and opportunities for the RI SPIN group.
To seek opportunities to collaborate with other SPINs for webinars, knowledge-sharing and to feedback on regulatory changes and interpretations.
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The purpose of the Digital health SPIN is to create a forum where TOPRA members working with digital health (including medical device software and artificial intelligence), or those interested in the topic have an opportunity to share knowledge and experiences.
The aim of this group is to organize quarterly webinars that are a mixture of webinars by invited guest speakers or members as well as informal discussions, and knowledge sharing.
Details of frequency of meetings of the committee: Quarterly
Agenda topics discussed at meetings: Medical Device Software, Artificial Intelligence, Software Device Lifecycle, Cybersecurity, Health Data, Interoperability
SaMD Committee members:
Célia Cruz
Angelina Munabi
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The Veterinary SPIN was established to provide a forum for TOPRA members involved in the veterinary / animal health field to exchange of information, discuss topics of mutual interest and share of experiences.
A small working group drawn from this SPIN is involved in the development and running of of the Veterinary Medicines programme of the TOPRA Symposium.
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