Enrol Before | 18 August To Save £400 | 20 September To Save £200
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,495 and live online is £1,395
£1,395.00
The price is for 2 days | Register for Module 1-Free
Master the quality module of the CTD with this comprehensive course
Discount has been applied to the price above. VAT, if applicable, will be added. The full price for the classroom option is £1,495 and live online is £1,395
The quality module of the Common Technical Document (CTD) presents the CMC (Chemistry, Manufacturing and Controls) data in the submission dossier for small and large molecules. Compiling the CMC regulatory material is challenging; however, module 3 must be completed with efficiency and accuracy to gain fast approval.
This training course examines the FDA and EMA regulatory requirements for both pharmaceuticals and biotech. It will give you the confidence to identify, compile and submit the correct information in the quality module. Once completed you will have a comprehensive understanding of key areas such as CMC regulatory strategy, building the pharmaceutical sections, creating the drug product sections, and creating the Quality Overall Summary (QOS).
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver classroom and live online training. If you have any concerns about COVID-19 before registering on to the course, please read our COVID-19 commitment.
There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
You decide what format is best for you. The course is delivered as a classroom (in-person) course that is also delivered online. You can decide whether you would like to attend in person or online. The price is dependent on the option.
We recommend visiting our website to learn more. Click here to learn more about hybrid training at Educo Life Sciences.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Most of our classroom courses are located at a venue in central London. The city has good transport links and is good place to socialise with fellow attendees. Accommodation is not included in the price. We recommend staying in a hotel within walking distance of the venue. Lunch and refreshments are included on all days where you will be able to interact with fellow peers and the trainers.
The course is held in the following venue:
Hallam Conference Centre, Cavendish Venues, 44 Hallam St, London, W1W 6JJ
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
Complete our contact form by following the link. Get in touch.
* | • The training course is delivered either online or in a classroom. Please check which course format you have booked. |
---|
Centrient (verified owner) –
n/a
Zyeco (verified owner) –
n/a
Owl Pharma (verified owner) –
n/a
Janssen Biologics (verified owner) –
What I enjoyed most from this training was the continuous interaction between the trainer and trainees. Even though this training was fully online, it was very practical, queries were addressed along the presentations. The fact that we were a small group created a safe environment where everybody was empowered to ask and debate anything.
Individual Booking (verified owner) –
n/a
Fresenius Kabi –
n/a
Martindale Pharma –
n/a
Asphalion –
Now, I understand the logic behind the CTD construction/writing and I gained the confidence at the time an eventual letter of deficiency is received.
Tiofarma –
n/a
The Reg Consultants –
n/a
Emmes (verified owner) –
n/a
BioVersys (verified owner) –
n/a
Thermo Fisher (verified owner) –
With over 10 years of industry experience, I have participated in numerous multi-day trainings. This particular one was exceptionally engaging, as the trainer’s energy level was just right to keep me focused on the material without feeling fatigued.
IMZ KFT –
n/a
Fresenius Kabi –
n/a
Union Therapeutics (verified owner) –
n/a
Sever Pharma Solutions –
The online course was great. The high level of competence in the area of the course leader and the professionality of the attendants drove the course into the main subject and rewarding discussions.