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Seeking parallel consultation from regulators and HTA bodies in Europe

Opportunities and challenges for drug developers

Whitepaper

Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help.

Drug developers who wish to gain European approval and access for new products must meet the evidence requirements of both the EMA and HTA bodies. Companies who engage early with the relevant agencies, including EUnetHTA, for scientific advice on evidence-generation plans can have a strong advantage.

Parallel consultations provide valuable feedback in generating optimal evidence to satisfy the needs of your key stakeholders. Ultimately, this can shorten development timelines and speed patients’ access to new treatments.

In this whitepaper we explore key factors when considering parallel consultation, to ensure that these meetings are well prepared, productive and informative.

Read the whitepaper to learn about:

  • The benefits of seeking early regulatory, HTA, and joint advice
  • Current trends in parallel advice, such as the use of real world evidence (RWE)
  • The pros and cons of using parallel consultation at the EU or national level
  • Strategies to maximise the benefits of parallel consultations through timing, briefing books and meeting content