Roderick Dirkzwager
Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.
Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.
With a broad life sciences practice, Roderick regularly advises on:
- EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
- commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
- regulatory and commercial due diligence for life sciences transactions; and
- intellectual property issues arising in corporate transactions and IP-related contracts.
Roderick is also a member of Covington's Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.
EU Talking Life Sciences Audiocast: WHO Prequalification Procedures in Africa
In this episode of Covington’s Life Sciences Audiocast, Mosa Mkhize and Roderick Dirkzwager discuss WHO prequalification procedures in Africa.
UK HRA Consults on a New Model Investigator-Initiated Study Agreement
Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners. The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.Continue Reading UK HRA Consults on a New Model Investigator-Initiated Study Agreement
EMA announces €10 million of funding to support the establishment of the African Medicines Agency
On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency…
Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines AgencyEU Talking Life Sciences Audiocast: Supplementary Protection Certificates – What It Means for a Product to Be Protected by a Basic Patent in Force and Future Proposals in the EU
Supplementary Protection Certificates (SPCs) are a form of patent term extension right that are available in the EU for medicinal products.
Tune into this episode of Covington’s Life Sciences Audiocast where Inga Pietsch and Roderick Dirkzwager discuss some of the developments in SPC case law from the European Court of…
Continue Reading EU Talking Life Sciences Audiocast: Supplementary Protection Certificates – What It Means for a Product to Be Protected by a Basic Patent in Force and Future Proposals in the EUEU Talking Life Sciences Audiocast: Clinical Trial Transparency Requirements in the EU
The EU Clinical Trials Regulation 536/2014 significantly expanded the transparency requirements for clinical trials in the EU, resulting in the public availability of most documents and information submitted by sponsors to the new EU Clinical Trial Information System. Tune into this episode of Covington’s Life Sciences Audiocast, where Robin…
Continue Reading EU Talking Life Sciences Audiocast: Clinical Trial Transparency Requirements in the EUEU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and Recast
On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU. The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023. The Commission intends…
Continue Reading EU Pharma Legislation Review Series: Unitary Supplementary Protection Certificates and RecastEU Pharma Legislation Review Series: Bolar Exemption under Patent Rights
The latest draft pharmaceutical legislation published by the European Commission (“Commission”) is set to shake up the regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU (as discussed in further in our previous blog). As part of these developments, the Commission has clarified the…
Continue Reading EU Pharma Legislation Review Series: Bolar Exemption under Patent RightsEU Pharma Legislation Review Series: Access to Documents and Transparency of R&D Funding
The EU’s latest draft pharmaceutical legislation contains some interesting developments on transparency matters, both in relation to access to documents and transparency around the funding of research and development of medicinal products.
1. Draft Regulation – Further Clarity Regarding Public Access to Documents
Disclosure of documents in response to an…
Continue Reading EU Pharma Legislation Review Series: Access to Documents and Transparency of R&D FundingEU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”). At the same time, the measures are also aimed at promoting and incentivizing the development of new…
Continue Reading EU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers