Launching a New Medicine (Training Workshop)

This online training workshop will take you through the processes of launching a new medicine - looking at various aspects from what evidence needs to be collected and why, and the regulator perspectives on what makes a drug a drug.

The workshop is newly developed and is geared towards a wide audience from pharmacologists to drug discovery scientists to regulators. It provides an introduction to the subject and goes further and so it is suitable for those new to the topic, as well as more experiences professionals.

The workshop will provide you with hands-on learning, and is discussion- and tutorial-based.

Topics

Non-clinical evidence
Evidence needed for regulatory approval and decision making boards for new medicine filing
Clinical Trial Authorisation (CTA) submission
Investigators brochure - core content and aim
Investigational Medical Procurement Dossier (IMPD)
Gaps in data – approached with a holistic view
Medicines and Healthcare products Regulatory Agency (MHRA) perspective – when can clinical trials start
Evidence base (non-clinical TOC, Pharmacokinetics (PK), translational medicine, 'Chemistry, Manufacturing, and Controls' (CMC)) – do these four combine to demonstrate success in humans?
Market Authorisation Application (MAA)
European Medicines Agency (EMA) and MHRA Assessors
How and why all information needs to be on the label, both good and bad

The session will mostly focus on aspects such as ideas and processes, as opposed to scientific aspects.

You can view and download a copy of the programme here

10:00 - 10:15	Welcome and plan for the day Renata Scalco
10:15 - 10:45	What critical attributes make a drug a drug Lutz Mueller
10:45 - 11:15	Regulatory perspective of drug development Lesley Narburgh
11:15 - 11:45	Breakout Session Attributes of a drug Lutz Mueller and Lesley Narbugh
11:45 - 12:00	Break
12:00 - 12:30	Review and decision - When is it safe to go into humans? David Jones
12:30 - 13:00	Clinical Pharmacology evidence building Helen Tomkinson
13:00 - 13:45	Lunch
13:45 - 14:15	Breakout Session Clinical PK Helen Tomkinson
14:15 - 14:45	Indication selection - proactive and reactive risks Aaron Deveney
14:45 - 15:15	Breakout Session Indication selection problem Aaron Deveney
15:15 - 15:25	Break
15:25 - 15:55	The clinical regulatory persective Kirsty Wydenbach
15:55 - 16:25	Breakout Session Regulators discussion - labels Kirsty Wydenbach
16:15 - 16:20	Wrap-up and revisit of learning outcomes Renata Scalco

You can view and download a copy of the speaker biographie s

Renata Scalco

Renata is a PhD neurologist with a strong focus on clinical development with international experience in neuromuscular disorders, neuropathy (muscle) and neurogenetics working at Roche. Industry experience: risdiplam (Evrysdi) for SMA - late clinical development/supporting filling activities/approval by different health authorities worldwide. Renata is a clinician and a scientist with a PhD in Translational Research in Neurology gained at the Queen Square Institute of Neurology, University College London (UCL).

Lutz Muller

Lutz is a Non-Clinical Project Leader and Chair of the Translational Safety Committee at Roche. Lutz has experience of many years of creating and regulating medicines with the German Health Authorirty (BfArM), Novartis and Roche. Lately, Lutz considers his chance to contribute to making the first small molecule mRNA splice modifier into an approved lifesaving drug a key achievement for a drug discoverer. He is proud to have been part of a team in the discovery and launch of Evrysdi (with risidiplam as its active ingredient). Evrysdi helps patients with SMA to survive and live a life full of hopes such as an other human being on this earth.

Lesly Narburgh

Lesly is Pharma Development Regulatory and Global Franchise Head of Rare Diseases and Neurodegeneration at Roche. Lesley has over 20 years' experience in the pharmaceutical industry; accountable for global regulatory management of complex projects, leading and line management for a global team of senior regulatory professionals; passion for rare disease and neurodegeneration drug development looking for innovative, patient centric regulatory solutions.

David Jones

David is a consultant Pharmaco-Toxicologist. David has a career spanning over 25 years at the UK Medicines and Healthcare products Regulatory Agency (MHRA). David is a European Registered Toxicologist as well as a Chartered Biologist and a Fellow of the Royal Society of Biology. He also lectures at the University of Surrey and the University of Wales. His many years experience at the MHRA provide invaluable insight to clients looking to take drugs to clinical trials.

Helen Tomkinson

Helen is Managing Director at Limina, a consultancy for Clinical Pharmacology and Bioanalysis. Helen is a highly motivated leader with a track record of setting strategy, building and motivating teams in the Clinical Pharmacology, Modelling and simulation and Bioanalysis fields. Helen has experience from AstraZeneca and specialised in oncology and anti-infectives. More recently Helen has developed broad cross therapy area expertise.

Aaron Deveney

Aaron is Vice President Clinical Development at Weatherden. Aaron is a senior specialist who has brought to market several compounds and brings extensive experience in the management of development programmes, strategic alliances, coordinating global business initiatives and portfolio management.

Kirsty Wydenbach

Kirsty is Head of Regulatory Strategy and Drug Development Clinician at Weatherden. Kirsty has extensive experience as an expert medical assessor of regulation in clinical trials and more than a decades experience at the UK Medicines

Tickets

Member Registration	Member Ticket	£145.00
Member Registration	Non-Member Ticket	£145.00
Non-Member Registration	Non-Member Ticket	£195.00

From

14 December 2023

Time

10am GMT to 4.30pm GMT

Launching a New Medicine (Training Workshop)

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