About this course
This unique course provides a comprehensive overview of the requirements of the Quality module of the ICH Common Technical Document (CTD) and links these to the reality of the manufacture of medicinal products and the need to comply with GMP. Non-compliance with registered commitments is an increasingly frequent regulatory inspection finding and one that potentially has very serious consequences for the company.
The ever-increasing complexity of obtaining approval for drug products requires that companies provide high quality registration applications and then maintain them once approved. To achieve this objective, it is essential that personnel in Regulatory Affairs, Research & Development, Manufacturing and Quality Assurance (especially the Qualified Person) understand regulatory requirements and work together as an effective team.
NSF Health Sciences and Regulatory Resources Group have once again combined their complementary skills to present this well proven and successful course which is designed to provide attendees with a clear understanding of the regulatory process and technical data requirements for registration and subsequent manufacture of medicinal products.
Although this course will primarily focus on EU aspects, consideration will be given to corresponding aspects in US submissions.
What You Will Learn
- Current regulatory requirements and their impact on Chemistry and Pharmacy registration requirements:
- European legal framework for medicinal products
- CTD submission structure and content
- Requirements for Drug Substance, including DMFs and CEPs
- CTD summary documents
- Pharmaceutical development, including impact of ICH Q8, 9 and 11
- Role of the EU expert
- Requirements for process and analytical validation
- EU marketing authorisation procedures
- EU clinical trial applications
- Post approval changes (variations)
- GMP inspections
- Role of the EU Qualified Person
Course outline
Legal framework for medicinal products
CTD submission structure and content for new and existing products
Data requirements for new and established products, with particular emphasis on:
- Drug substance information, including drug master files and certificates of suitability
- Pharmaceutical development including impact of QbD
- Manufacturing processes and validation
- Control of excipients
- Control of drug products – specifications, control methods and analytical validation
- Container closure systems
- Stability
CTD summary documents
The role of the EU expert
EU marketing authorisation procedures
EU clinical trial application requirements
Post approval changes (variations)
Manufacturing authorisations – for commercial and clinical trial products
GMP inspections and regulatory compliance
Risk assessment in Regulatory Affairs
Role of the EU Qualified Person:
- Discretion when releasing batches
- GMP declarations
- Interface with Regulatory Affairs
Discussions and Working Groups
A significant proportion of course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Renaissance Manchester City Centre Hotel, Manchester, UK
Located in one of the most exciting cities in UK, the 4 star Renaissance Manchester Hotel is at the heart of Manchester’s entertainment quarter. The hotel features one of the largest conference venues in the city which also provides wireless internet access.
The hotel offers spacious bedrooms with air conditioning, lounge area, excellent workspace and WIFI access.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Renaissance Manchester City Centre Hotel
Blackfriars Street
Manchester
M3 2EQ
England
Tel: +44 (0) 1618 316 000
Fax: +44 (0) 1618 353 077
www.marriott.co.uk
Hotel Bookings
If you would like to benefit from our specially negotiated bed and breakfast rate with the hotel, please book your accommodation following “this link - link to be confirmed shortly”
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
- Shaun Stapleton, Regulatory Resources Group, UK - Shaun is a Director of RRG and has wide-ranging experience in regulatory affairs gained in consultancy and various positions in the pharmaceutical industry
- Helen Erwood, Regulatory Resources Group, UK - Helen has worked within the pharmaceutical industry for more than 20 years. Helen brings to the course an enthusiasm for, and a broad experience in, global Regulatory Affairs
What you've said
“I have never enjoyed another course as much as this! The experiences gained here will remain with me throughout my career! I feel much more confident about being a Regulatory Affairs person.”
Melanie Govender, Sanofi-Aventis, UK
“Content covered every aspect relevant to myself and gave good background on other areas. Course tutors were all excellent and worked brilliantly together.”
Marianna Richard, MundiPharma Research, UK
“It was just great to join this course and it helped me a lot as a beginner to receive a wide spectrum of CTD information and regulatory knowledge/information.”
Verena Thomas, Novartis Pharma, Switzerland
“Overall a very interesting and beneficial course – covers a wide range of information in detail.”
Louise Griffin, Almus Pharmaceuticals, UK
“A very comprehensive grounding in what, for me, is a fairly new subject.”
Justin Barry, Midatech Biogune, Spain
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