This in-person training program on documentation, regulation and regulatory affair aspects of medicinal product labelling and packaging in the EU will discuss:
- The SmPC forms and marketing authorisation
- Product Information, Product Characteristics (SmPC), labelling text and package leaflet
- Content approval process and competent authority
- Role of SmPCs in marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively.
- The lifecycle of a medicine
- How the SmPC should be worded (clear and concise language)
- SmPCs and documentation, and information required for patients
- Guidance documents required to pass "user testing" for medicinal product approval in EU
Learning Objectives:
Upon completion of this course, each participant will have a comprehensive knowledge and understanding of development regulatory affairs. Participants will have learned the following:
- Which are the important EU product information guidance documents for the SmPC;
- Which guidelines on the packaging information and excipients are important;
- How to perform consultation with Target Patient Groups
Who will Benefit:
This course is specifically designed for personnel in the pharmaceutical and biotech industries. Following personnel will benefit from the course:
- Regulatory Affairs Officers and Managers
- Labelling and Packaging
- Documentation
- Product Development
- Consultants
- Medical Safety
- Medical Writer
- Clinical
- Quality Assurance/Testing
- Personnel in other departments that need to understand the requirements for Product Information
Topic Background:
Product Information consist of the Summary of Product Characteristics (SmPC), labelling text and package leaflet. The SmPC forms an intrinsic and integral part of the marketing authorisation. It sets out the agreed position of the medicinal product as distilled during the assessment process. As such the content cannot be changed except with the approval of the originating competent authority.
SmPCs are a key part of the marketing authorisation of all medicines authorised in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge. The SmPC should be worded in clear and concise language. SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients. This webinar provides advice on the principles of presenting information in the SmPC.
The text on the label and the package leaflet are usually the only items the patient will see from all documents included in a marketing authorization application, so it is very important that the texts are clear and of a high quality. Knowledge of how to write a package leaflet and which guidance documents are important is also vital to pass the so-called "user testing" which is mandatory before a medicinal product can be approved in the EU.
Deviation from the guidelines should be justified in the Marketing Authorisation Applications. This seminar provides an overview of the relevant guidance documents and practical advice of how to write the Product Information.
- Registration Process: 8:30 AM – 9:00 AM
- Session Start Time: 9:00 AM
- The SmPC
- The role of the SmPC (including use as Pharmacovigilance Document)
- Where does the information come from?
- Structure of the Common Technical Document
- Structure of SmPC in reference to difference Modules
- Structure of SmPC in reference to departmental responsibilities (PV, Clinical, Quality, etc.)
- Relationship between Modules, SmPC, PIL, Labelling – the last three being the only key information seen by general public / med practitioners
- How to write an SmPC from scratch
- Presentation and discussion of key guidance documents (including templates) from EMA/CHMP
- The importance of writing the SmPC so that it will be precise, exact, readable, and unambiguous
- Clarifying the therapeutic indications
- Listing contraindications
- Defining the warnings and precautions for use
- Highlighting potential drug interactions
- Defining instructions for proper use, improving tolerance to medicines by communicating necessary safety information and avoiding untoward effects
- Describing adverse reactions from clinical studies and spontaneous reporting and how it may influence pharmacovigilance
- Describing instructions for storage, shelf life and in use stability claims
- Timing of reporting the date of last revision
- Translations
- The package leaflet
- Relationship between SmPC / Package Leaflet
- Differences
- What is reflected where and in what format?
- The perception of risk of a medicinal product
- Guidelines for package leaflets
- Combining package leaflets for different pharmaceutical forms, presentations and strengths of a medicinal product
- The package leaflet as a marketing tool, what is allowed?
- Practical exercises: Successfully working through the Regulations
In this session participants will be able to analyse the regulatory requirements and will gain an in-depth knowledge of how to meet them. The emphasis will be on grasping what information is required. This is a unique opportunity for the participants to ensure they fully understand and comply with the regulations in place.
- Participants will work on the following points:
- Understanding what must be included in your Patient Information Leaflets (PLs) with a focus on safety
- Overcoming the special challenges when drafting the safety sections on contraindications, warnings and precautions
- Practical exercise 1
- Writing a package leaflet, based on an SmPC
- Practical exercise 2
- Improving a package leaflet, making it more clear and patient-friendly
- Participants will work on the following points:
- Labelling
- Relationship between SmPC / Labelling
- Requirements for labels
- Minimum information on small labels
- Labelling as a marketing tool, what is allowed?
- Practical exercise 3
- Writing the label text, based on an SmPC
- Safety and liability
- How must safety information be presented to the patient that would prevent very severe consequences such as foetus deformity - be included in leaflets
- How does a company manage this by region?
- How often should a SmPC leaflet be reviewed? Relationship with PSURs.
- Risk-Management Plans and how they affect product information
- Readability Testing
- Legal requirements
- Language requirements
- Where to test
- Pitfalls in developing a test
- Interviewing focus groups
- Bridging tests
- Inclusion and exclusion criteria
- Practical exercise 4
- Conduct readability testing with the participants
- Product Information during the registration procedures
- Before submission
- Steps to consider after submission and before marketing approval
- What to agree to and what not to agree to when negotiating with the Health Authorities
- What to do after CHMP opinion until EU Commission authorisation
- Product Information after approval
- Overview of Variations
- Variations involving Product Information
- Variations for generic/hybrid/biosimilar products
- Variations following referrals
- Implementation of Pharmacovigilance requirements
- What to do with editorial changes?
- When to submit the translations
- Article 61(3) Notification
- International situation
- Comparing US labelling, the Package Insert; also the complementary Medication Guide for the high risk drugs under a REMS
Adriaan Fruijtier
Regulatory Affairs Consultant
Adriaan Fruijtier graduated as a pharmacist from the University of Utrecht, Netherlands. Until March 2004, he headed the oncology group within global regulatory affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was director of regulatory affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet, he served as a project manager for oncology projects at the European Medicines Agency for four years in London.
He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was regulatory affairs project manager in the oncology group between 1996 and 1997. Before 1996, he was head of drug regulatory affairs for six years at Ciba-Geigy in the Netherlands, and has worked as manager regulatory affairs at Glaxo, also in the Netherlands.
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- A half page brochure advert
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- A quarter page brochure advert
- Moving banner ad on the website
- Logo on name cards
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- Logo on the lanyards for all speakers
- Exclusive stall at the entrance
- A full page brochure advert
- Moving banner ad on the website
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Local Attractions of Austria, Vienna
Schonbrunn Palace
Schonbrunn Palace is a former imperial summer residence located in Vienna. The 1,441-room Baroque palace is one of the most important architectural, cultural, and historical monuments in the country. Since the mid-1950s it has been a major tourist attraction. The history of the palace and its vast gardens spans over 300 years, reflecting the changing tastes, interests, and aspirations of successive Habsburg monarchs. The Great Parterre of Schönbrunn is lined with 32 sculptures, which represent deities and virtues. The sculpted garden space between the palace and the Sun Fountain is called the Great Parterre. The French garden contains, among other things, a maze. The complex includes many more attractions: besides the Tiergarten, an orangerie erected around 1755, staple luxuries of European palaces of its type, a palm house is noteworthy. Western parts were turned into English garden style in 1828–1852. The area called Meidlinger Vertiefung to the west of the castle was turned into a play area and drill ground for the children of the Habsburgs in the 19th century. At this time it was common to use parks for the military education of young princes.
Belvedere Palace
The Belvedere is a historic building complex in Vienna, Austria, consisting of two Baroque palaces (the Upper and Lower Belvedere), the Orangery, and the Palace Stables. The buildings are set in a Baroque park landscape in the third district of the city, on the south-eastern edge of its centre. It houses the Belvedere museum. The grounds are set on a gentle gradient and include decorative tiered fountains and cascades, Baroque sculptures, and majestic wrought iron gates. The various sections of the original orangeries annexed to the Marble Hall were returned to their original condition and now provide space for the new exhibition rooms. The magnificent Baroque state rooms – the Marble Gallery, the Golden Room, and the Hall of Grotesques – remain unchanged and are open to the public.
Prater
The Prater is a large public park in Vienna's 2nd district (Leopoldstadt). The Wurstelprater amusement park, often simply called "Prater", lies in one corner of the Wiener Prater and includes the Wiener Riesenrad Ferris wheel. On the grounds of modern-day Kaiserwiese, an attraction called "Venice in Vienna” was established in 1895 by Gabor Steiner. The area included an artificial lagoon to simulate the canals of Venice, Italy. In 2004, major renovations to the Wurstelprater began, and a new underground railway line was finished and brought into service on May 11, 2008, which includes three stops along the Prater. The Hauptallee (main avenue) is the main artery, lined with horse chestnut trees, closed to motorists and known to sports enthusiasts from the annual Vienna Marathon. The Wiener Prater is home to the Liliputbahn, a narrow gauge railway. Another unusual object to be found in the Wiener Prater is the Republik Kugelmugel (Republic of Kugelmugel), a spherical micronation. The Wiener Prater also houses a planetarium and the Prater Museum.
Vienna Ring Road
The Ring Road (German: Ringstraße) is a circular ring road surrounding the Innere Stadt district of Vienna and is one of its main sights. Constructed in the mid-19th century after the dismantling of the city fortification walls, its architecture is typical of the eclectic, historicist style called Ringstraßenstil (Ring Road Style) of the 1860s to 1890s. Known for its unique architectural beauty and history, it has also been called the "Lord of the ring roads", and is inscribed by UNESCO as part of Vienna's World Heritage Site. Sigmund Freud was known to take a daily recreational walk around the Ring. The Ringstraße has several sections. It surrounds the central area of Vienna on all sides, except for the northeast, where its place is taken by the Franz-Josephs-Kai, the street going along the Donaukanal (a branch of the Danube).
Kunsthistorisches Museum
The Kunsthistorisches Museum (English: "Museum of Art History", also often referred to as the "Museum of Fine Arts") is an art museum in Vienna. Housed in its festive palatial building on Ringstraße, it is crowned with an octagonal dome. The term Kunsthistorisches Museum applies to both the institution and the main building. It is the largest art museum in the country. It was opened around 1891 at the same time as the Naturhistorisches Museum, by Emperor Franz Joseph I of Austria-Hungary. The two museums have similar exteriors and face each other across Maria-Theresien-Platz. The museum's primary collections are those of the Habsburgs, particularly from the portrait and armour collections of Ferdinand of Tirol, the collections of Emperor Rudolph II, and the collection of paintings of Archduke Leopold Wilhelm.
