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Take a jumble of ideas, needs, and requests and turn it into a well-defined project brief
Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.
The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.
Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.
This video course takes you through the basic and advanced concepts of penetration testing. From setting up your own virtual lab to developing brute force attacking tools using Python, you'll learn it all with the help of engaging activities.
Our up-to-date course covers the latest PMBOK 6, 7, and Agile updates, providing a simplified guide to project management. Learn the framework, processes, and knowledge areas, and see how they work together to manage projects and stakeholders. It is perfect for those seeking to efficiently manage projects and pass the PMP exam.
LOOKING FOR: ADULT FICTION, NON-FICTION Daisy Chandley joined PFD in 2019 after graduating from the University of Oxford with a BA in Politics, Philosophy and Economics. She is an Associate Agent and assistant to Senior Agent Annabel Merullo and Head of Books Tim Bates as the UK sub-agent for New Directions Publishing in the US. Daisy is actively building a list of both fiction and non-fiction authors across a range of genres. With fiction, Daisy's wishlist roughly falls into three categories – if something feels like it overlaps between them, even better! 1) Sharp, original novels on the literary to upmarket spectrum, all the way from deeply dark and boundary-pushing books like Hurricane Season, Under The Skin or In The Cut to those balancing edge, heart and humour, like Detransition, Baby or A Visit From The Goon Squad. She loves irreverent wit, daring approaches in narrative or form, and seriously unsettling stories in equal measure, and if you can bring a few of those elements into one, it’ll go straight to the top of her. 2) Com-heavy rom-coms, whether in the dry but ultimately sob-inducing vein of Greta and Valdin or a Nora Ephron film, the escapist screwball delight of a Cary Grant classic, or the more unusual, genre-bending style of something like Palm Springs. Daisy is a sucker for Emily Henry and will always be happy to see an innovative take on tropey love stories, but is equally very keen to see to things a bit outside of the box, whether that’s integrating speculative elements, dark humour, or topical issues. In any case, humour and originality are my priority, and affectionately snarky bickering is the best way to make her fall head over heels with a couple. 3) Sleuths! Daisy is not the right person for police procedurals, but loves classic detectives and amateur sleuths. Whether it’s a delightful Knives Out or Nancy Drew homage or an intricate, unputdownable mystery on the darker side, the minute someone finds a good old fashioned clue, count her in! Overall, whether it’s a delightfully fun and scandalous page-turner or something really bold and experimental, if it’s stylish and smart – and maybe even a bit sexy – Daisy would love to see it. Daisy is definitely interested in literary speculative fiction, though not generally looking for hard SFF. Across the board, she is always looking for stories that explore sexuality, race, gender, and disability, and would particularly love to hear from writers whose voices and experiences aren’t given enough space in publishing. On the non-fiction side, Daisy is looking for bold new insights and underrepresented voices on popular science, nature writing, relationships, social issues and politics, and am always especially interested in fresh, playful and exciting writing on pop culture, love and the internet. She’d also love to see illuminating narrative non-fiction, whether a beautiful and lyrical exploration, or an enthralling and explosive deep-dive. A (large) handful of authors past and present whose work Daisy loves include Patricia Lockwood, Toni Morrison, Elif Batuman, Gillian Flynn, Shirley Jackson, Raven Leilani, Max Porter, Carmen Maria Machado, Virginia Woolf, Sayaka Murata, Kiley Reid, Sally Rooney, George Saunders, Joan Didion, Amy Liptrot, Ottessa Moshfegh, J.D. Salinger, Donna Tartt, Bret Easton Ellis, and Fernanda Melchor. Daisy is not the right fit for Children’s or YA authors. Daisy would like you to submit a covering letter, 1 page synopsis and the first 2,500 words of your manuscript in a single word document. (In addition to the paid sessions, Daisy is kindly offering one free session for low income/under-represented writers. Please email agent121@iaminprint.co.uk to apply, outlining your case for this option which is offered at the discretion of I Am In Print). By booking you understand you need to conduct an internet connection test with I Am In Print prior to the event. You also agree to email your material in one document to reach I Am In Print by the stated submission deadline and note that I Am In Print take no responsibility for the advice received during your agent meeting. The submission deadline is: Wednesday 11 September 2024