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BioPharma First Consultancy

General Information

Identification Code: 683233452237-70
Entity Form: sole proprietor
Registration Category: Non-governmental organisations, platforms and networks and similar
Registration Date: 12/12/2023
EP Accredited Number: 0

Mission & Interests

Goals: I am committed to delivering expert consultancy, coaching, business and educational services related to the pharmaceutical and health(care) space. With a specific focus on the entire (bio)pharmaceutical product development lifecycle, including Cell and Gene Therapies, I play an active role in advancing initiatives that support health policy, regulatory excellence, and strategic/operational management. Providing my input to key programs: EUHTA Regulation 2021/2282, the Scientific Committee on Consumer Safety (SCCS) and leveraging my experience as a mentor, my objective is to facilitate the seamless integration of innovative medicinal technologies, evidence-based practices, and safety assessments into healthcare systems. This commitment aligns with the overarching goals of the European Commission and DG SANTE.
Interests Represented: Does not represent commercial interests
Interests:
  • Business and industry
  • Consumers
  • Education and training
  • Public health
  • Research and innovation
Levels of Interest:
  • european

Activities

Main EU Legislative Proposals: - Regulation (EU) 2021/2282 (HTAR) (former stakeholder of EUnetHTA21, member of the EUnetHTA network, specializing in Cell and Gene Therapies, ATMPs, and novel medicinal technologies) - Regulation (EU) 2017/746 (IVDR) (previous work related to in vitro medical tests and biomarkers) - Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health (participant of the EUHPP meetings) - New Pharmaceutical Regulation - Regulation INTERINSTITUTIONAL AGREEMENTS of 20 May 2021 between the European Parliament, the Council of the European Union and the European Commission on a mandatory transparency register In my capacity as an expert for the European Commission (ID: 2022D678908), I actively engage in public consultations concerning various EMA/EC documents and guidelines related to healthcare systems and emerging technologies/products (see above).
Communication Activities: My contributions encompass specialized knowledge in Single Arm (Clinical) Trials (SAT) and external comparators, Real-World Data/Real-World Evidence (RWD/RWE), as well as the application of Artificial Intelligence (AI) across the entire pharmaceutical product development lifecycle. Additionally, I provided expertise on safety assessments of chemicals - components of products including pharmaceuticals and cosmetics (permanent dyes, derivatives of PPD)(NAM) in the context of Comments on draft OPINION on Hydroxypropyl p-phenylenediamine and its dihydrochloride salt, also related to REACH and I am participating in public consultations related to Regulation COM(2023)783 and Staff working document SWD(2023)850. As a member of the EUnetHTA network and former stakeholder of EUnetHTA21 I contribute to methodological and procedural guidelines in the context of HTAR 2021/2282 within the framework of EMA scientific advice and Health Technology Assessment (HTA). I am active by using various communication channels and opportunities to meet with regulators and various stakeholders during: - EU (Business) Health Summits - Mental Health Stakeholder Meeting - Economist Impact Event (Beating Cancer Plan/Mission) and EU's Beating Cancer Plan Congresses - Meetings organized within the EU4Health frameworks (operational/strategic) - EMA events on ACT EU and CTIS initiatives as well as Soft tissue and bone sarcoma workshop: how can we develop new treatments in ultra-rare sarcomas, as a model for ultra-rare tumours? - Shaping a European innovation ecosystem: EU-Innovation Network multi-stakeholder meeting, jointly organised by AEMPS and the European Innovation Network - One Health conference - EUnetHTA stakeholder meetings and part of series of events related to implementing the EU Health Technology Assessment - EUHPP webinars - International Innovation & Collaboration Summit (LSOS) - Delivering CGT/ATMPs Courses to groups of technology developers and regulators (US/EU)
Inter-institutional or Unofficial Groupings: Unofficial groupings

Head Office

Address: Weezenhof 3728
Post Code: 6536HJ
City: Nijmegen
Country: NETHERLANDS
Phone: [object Object]

EU Office

Address: Weezenhof 3728
Post Code: 6536HJ
City: Nijmegen
Country: NETHERLANDS
Phone: [object Object]

Financial Data

New Organisation: false
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Current Year: [object Object]
Complementary Information: - My courses offered as consultancy services on Cell and Gene Therapies, regulatory and policy took place in 2023, with two editions tailored for technology developers and innovators in the EU, Canada, and the US. - Pro-bono activities for EIT Health Mentoring and Coaching Network in 2022 (financial obligations were not fulfilled by a start-up receiving mentoring and coaching services). - Pro-bono activities within the framework of EWE Mentor Academy between 2022 - 2023 (Participation in webinars and the review of newly created educational material, RescEWE, which received the European Enterprise Promotion Award 2023 in the category 'Investing in Entrepreneurial Skills). - Pro-bono activities within the framework of EunetHTA 21 stakeholder meetings in 2022 - 2023 - Pro-bono activities during public consultations to EMA/EC on regulations and guidelines related to health care, medicinal technologies and Regulation COM(2023)783 & Staff working document SWD(2023)850

Membership Information

Members10 Percent: 0
Members25 Percent: 0
Members50 Percent: 1
Members75 Percent: 0
Members: 1
Members F T E: 0.5
Info Members: May vary, depending on activities and workflows

Structure

Structure Type: Structure
Is Member Of: - Member of the EUnetHTA Network (https://www.linkedin.com/in/eunethta/) - Former member of EIT Health Mentoring & Coaching Network (Innovators Alumni Network) (https://eithealth.eu/programmes/mentoring-and-coaching-network/) - Participation in events organized by EWE Mentor Academy (Platform for Experienced Mentors to support SMEs) (https://www.earlywarningeurope.eu/) - Interested in participation in EU Health Policy Platform (https://webgate.ec.europa.eu/hpf/) and & Critical Medicine Alliance (https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/overview/critical-medicines-alliance_en)
Organisation Members: - Member of the EUnetHTA Network (https://www.linkedin.com/in/eunethta/) - Former member of EIT Health Mentoring & Coaching Network (Innovators Alumni Network) (https://eithealth.eu/programmes/mentoring-and-coaching-network/) - Participation in events organized by EWE Mentor Academy (Platform for Experienced Mentors to support SMEs) (https://www.earlywarningeurope.eu/) - Interested in participation in EU Health Policy Platform (https://webgate.ec.europa.eu/hpf/) and Critical Medicine Alliance (https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/overview/critical-medicines-alliance_en)