01.12.23 -- When Will Full Adherence To EU (536/2014) Be Required?

In January 2022, EU (536/2014) — a binding regulation across all members of the EU — came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.

If a medicine’s sponsor wants to maximize the impact of a product on patients, providers, and their own bottom line, the need to proactively make regulatory affairs part of the lifecycle planning strategy is critical to the planning process.

Discover why a clinical study protocol needs to be presented using clear and unambiguous essential rules to facilitate the compliance of all study stakeholders.

Learn how a dermatology specialized European CRO joined forces to carry out interim statistical analysis in its study on seven subjects and prepare necessary data packages.

Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. While Part 11 is widely known, explore how it fits in with your research software.

Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start and position themselves as industry leaders.

One of Premier Consulting’s differentiating offerings is the portfolio analysis: a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio.

Novotech’s medical and regulatory consulting team offers a full range of preclinical, regulatory affairs support, medical, and pharmacovigilance consulting services.

For years, Boehringer Ingelheim operated with a system composed of best-of-breed solutions from different vendor companies. After carefully evaluating the technology environment, the company decided to move from best-of-breed solutions to an end-to-end product development platform.

Fifty CROs were evaluated on more than 20 performance metrics. Research participants were recruited from biopharmaceutical companies of all sizes and were screened for decision-making influence when it comes to working with outsourcing partners. Find out the results in this report.

Read about the continuous evaluation and varying opinions regarding the strategic resourcing models employed within the biopharmaceutical sector today.

Our team of industry experts has extensive experience developing and delivering quality services for data management departments across all major therapeutic areas and phases for pharma/biotech companies.