The objective of the training course “Drugs registration requirements in extra-EU countries” is to illustrate, through practical examples, the registration processes in various geographical areas and the most effective strategic approach to reduce the risks of slowing down or failing in the registration process. The regulatory world is constantly changing, with Europe and the United States being the pioneers in drug and active ingredient (API) regulation. The registration process for APIs in these two geographic areas has been standardized for several years now. In non-EU nations, such as Brazil, Korea, and China, areas of interest for business development, registration is brokered by an agent and/or client according to the country’s regulations, often expressed in the local language. How does one register an Active Principle in such nations? What are the timelines? What is the approach of the respective regulatory authorities? Find it out with the training course “Registration requirements in extra-EU countries”.
ARE YOU INTERESTED IN REGULATORY AFFAIRS TRAININGS?
Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:
- Impact of variations on the site regulatory and compliance activities
- La registrazione di un farmaco: focus sulle linee guida di tossicologia e struttura CTD per la sezione preclinica
- Skilful drafting of technical documentation
- Drugs registration requirements in extra-EU countries
- Basic training in Regulatory Affairs
- Common Technical Document (CTD) module 3: focus on the most critical aspects
- Marketing Authorization Holder (MAH), Regulatory Affairs and Qualified Person: responsibilities and interactions for GMP compliance
(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.
Key points of the training
- The different types of registrations in: Brazil, Korea, China
- The different types of CTD
- The roles of key figures in the registration chain: assessors, agents, and clients
- The different technical and cultural approaches to these figures
09:00 – 13:00 COURSE SESSION
- Module 3.S main differences between EU and non-EU countries
- Registration in Brazil
- Registration in Korea
- Registration In China
Professionals involved in the pharmaceutical sector: Regulatory Affairs, Quality Assurance and Sales.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email firstname.lastname@example.org within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting email@example.com. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Llifescience consultant, business coach
She has thirteen years of professional experience in chemical-pharmaceutical companies with different production sites, types of products (finished products and/or active ingredients), types of markets and different Regulatory Authorities around the world. She has a strong background in Regulatory (FDA, ICH, EudraLex,) RDC (Brazilian API Regulatory) and other CMC requirements for different types of authorities around the world, as well as Quality Assurance regulations (GMP, ICH, EudraLex, Pharmacopoeia, ISPE). Inspection experience from AIFA, FDA, Swiss Medic.
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