Jumar Masterclass: Regulatory pathways/strategies for pharmaceuticals

Struggling to navigate the intricate world of pharmaceutical regulations? 

Whether you're an industry veteran or new to the field, understanding regulatory pathways is vital for success. That's why we're excited to introduce our next Jumar Masterclass, where we'll unravel the complexities, provide practical guidance, share proven strategies, and offer real-life examples to empower you in this critical domain.

The Speakers:

Nicoletta Muner - Managing Director (MPharmSci GAICD) Canary Regulatory Affairs

Nicoletta, a pharmaceutical professional, began her career as an analytical chemist and formulation scientist, gaining expertise in drug development, project management, manufacturing scale-up, quality management, and validation. She played a pivotal role in transitioning the generic industry toward more complex generics and biosimilars. As the Global Director of Regulatory Affairs at an Australian company, Nicoletta led regulatory procedures that resulted in the approval of the European Marketing Authorisation Application (MAA) and US New Drug Application (NDA) for a groundbreaking orphan drug with a complex dosage form. She also contributed to non-clinical development and supported the clinical program, preparing the US Investigational New Drug (IND) application. She has also founded Canary to advance global access to new treatments.

More speakers TBC

Key Topics We'll Explore:

1. Planning for Regulatory Approval: Learn the essential steps to secure regulatory approval successfully.
2. US vs. EU Processes: Discover the similarities and differences in regulatory processes between the US and EU.
3. Aligning with Clinical Trials: Understand how to align your regulatory strategy with clinical trial design and implementation.
4. Market Entry Strategy: Explore the connection between regulatory strategy and market entry, including reimbursement and partnerships.
5. When to Seek Regulatory Support: Uncover the signals that indicate when you should seek guidance from a regulatory specialist.
6. GMP Manufacturing Standard: Explore the benefits of utilizing GMP manufacturing standards in early clinical trials.
7. Do's and Don'ts: Gain valuable insights from real-life examples that highlight best practices and common pitfalls.

The masterclass will be followed by a tour of Jumar Bioincubator. Let us know in the registration form if you're interested in joining.

About 

Set to open it's doors in late 2023, Jumar Bioincubator will act as a first home for biotech startups, providing affordable lab and office space, practical support, and community activities to unlock the potential in early scientific discoveries.

Jumar Bioincubator was established by CSL, WEHI and the University of Melbourne. Together, with backing from innovation investor Breakthrough Victoria and operator Cicada Innovations, the mission is to connect early-stage and scaling biotech ventures with the support they need to progress discoveries towards real-world treatments and therapies and build a critical mass of scientists with the knowledge and confidence to run successful biomedical ventures.