One of the results of the recently approved EU Falsified Medicines Directive imposes the application of a Unique Product Identifier and a Tamper Evidence Feature. This is only the top of the iceberg. It is not just printing a code and adding a label on a box, it means Authentication Data Flow, design the proper IT architecture, learn a new way of handling the products with a precise deadline: February 2019.
From this date all prescription products (with some exceptions)
must be serialized and data must be loaded into the EU hub.
Sharp can support you, thanks to 8 years of experience, 2 billions of sales units serialized to date, 4 plants already serializing for USA (US Drug Quality Security Act enforced from 27th November 2017), China, Brazil, South Corea.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
The Falsified Medicines Directive - Regulation Driving DigitisationAegate
"The Falsified Medicines Directive - Regulation Driving Digitisation" by Graham Smith of Aegate.
Presented at The European Generic Medicines Association’s Annual Conference, Madrid
June 25-27th 2014
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
The Falsified Medicines Directive - Regulation Driving DigitisationAegate
"The Falsified Medicines Directive - Regulation Driving Digitisation" by Graham Smith of Aegate.
Presented at The European Generic Medicines Association’s Annual Conference, Madrid
June 25-27th 2014
Counterfeit Herbal Medicine adulterated with chemical drugs in Indonesia: NAD...Premier Publishers
Herbal medicine is widely used in Indonesia. Thus, counterfeit herbal medicines are a great concern given the negative impact to individual and population health. This paper used data drawn from the National Agency of Drug and Food Control (NADFC/BPOM)of Indonesia to describe the counterfeit trend against registered herbal drugs from 2011 to 2014, and further analyses were performed to discover the types of the fraud, the impact to the health and conventional drugs that could be used as substitutes for herbal drugs. The research found that the amount of falsified medicines is increasing along with the increasing number of registered herbal drugs. From the data obtained, similar falsified herbal drugs were identified for both life style drugs (51%) and health-related condition drugs (49%). In addition, almost all falsified herbal drugs are adulterations plus tampering (81%). The most significant substitute chemical drug is paracetamol.
Counterfeit Products are epidemic in all product categories, but - unlike luxury goods – fakes and counterfeit pharmaceutical products endanger lives, either through their lack of active ingredients or the inclusion of harmful substances.
(The WHO estimates that over 30% of pharmaceuticals in developing countries are fake).
In this document, we would like to request your support for a field study of our latest mobile visual forensics application that is intended to provide quick, reliable and cost effective identification of counterfeit pharmaceutical goods.
http://www.e-mundo.de
From documents to datasets and back: challenges and solutions Jan Voskuil
The upcoming effectuation of the IDMP directive (EU) forces pharma companies to submit datasets instead of documents. Based on state of the art entity extraction software, a solution is developed that generates those parts of the dataset that can be obtained from the text. The presentation describes some of the major challenges that had to be overcome and details the solutions that were found. It presents some results and describes the major business requirements that need to be met. Recognizing named entities, such as headache and nausea, in the text is not enough. The extraction software needs to be embedded in a layer of software that analyses the text and recognizes which entities are the value of which properties.
Pharma datamatrix identification and serialisationZetes srl
Learn how our solution offers protection against
1
Counterfeit: unauthorized product introduced into the legitimate distribution network
2
Theft: stolen from the legitimate distribution network
3
Derivations: unauthorized sale of a product based upon contractual restrictions (ex: subcontractor manufacturer)
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
SMi Group announces the return of its 11th annual Pharmaceutical Logistics conference to London on the 18th- 19th May 2017. Outsourcing logistics tasks to third parties has been observed as an emerging trend in the global market and it is only expected to gain momentum in the coming years
Updated February 2017: This slide deck gives background to, and an update on, the Falsified Medicines Directive and Delegated Regulation. More more information about the FMD, please visit: http://www.abpi.org.uk/our-work/falsified-medicines-directive/Pages/default.aspx
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
DSCSA and Blockchain, Global Governmental
perspective of Blockchain implementation in medtech Medtech
Possibilities
Information such as place of production
of active substances or component
parts, manufacturing locations, shipping
dates, batch numbers, expiry dates,
storage temperature and unique
identification numbers, could all be
stored and monitored on blockchain.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
A Closer Look At Brazil’s New Serialization RegulationShari Popovich
Brazil has gone through several attempts at defining its pharmaceutical serialization and traceability regulation. The newest version of the law requires ANVISA to develop new regulations, which should result in a more attainable architecture.
In this webinar, Dirk Rodgers, Regulatory Strategist at Systech International, will review the features of the new law and the recent draft of regulations from ANVISA. He will also give his quarterly overview of regulatory developments around the rest of the world.
Presentation: The Australian Pharmacovigilance Inspection Program (PVIP)TGA Australia
Presentations given at the TGA information sessions cover the pharmacovigilance inspection guidelines, preparing for inspections, inspection process, and close out of inspections.
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
'Connected healthcare - connected to legality?'Lucy Woods
In January 2016, we held a Legal SIG (special interest group) at the London HQ of Olswang. Speakers included Juma El-Awaisi of Braci, Ross McKean of Olswang and Ken Munro of Pen Test Partners. Ken's presentation was interactive so slides are coming soon!
Therapeutics Goods Administration(TGA) is a unit of the Australian Government Department of Health and Ageing, is responsible for administering the act.
As a very critical industry for the health and well-being of people all over the world, the global food industry is subject to a vast amount of regulations throughout the global supply chain. With ongoing technical progress in automation and data processing, regulations will not only continue to grow, but will also demand more and more input from all participants in the supply chain. To achieve compliance with growing global regulations, it will become necessary
to provide fully traceable evidence about all supply chain movements from raw materials to the finished product. Looking beyond regulations, having full transparency and control over your supply chain can also result in fundamental advantages over the competition. If the available data is used properly, it can be harnessed and leveraged to gain a strategic business advantage including improvements in the overall supply chain procedures and a boost in customer trust and confidence by providing transparency about food origins.
Now is the time to take action and evolve your supply chain strategy...
Now is the time to move beyond simply meeting the minimum expectations of regulatory guidelines and evolve to a more strategic approach to complete supply chain integrity...
Now is the time to keep your company out of the headlines because of a recall or compromised link in your extended supply chain...
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
August 7, 2013 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focused on:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ cosmetic regulation
ANDAs, OTCs, Orphans and Cosmetics – Key IssuesMichael Swit
June 24, 2015 lecture to RAC Test review course sponsored by San Diego Regulatory Affairs Network (SDRAN). Focus:
♦ ANDAs and generic drug regulation
♦ OTC drug regulation
♦ Orphan drug regulation
♦ Cosmetic Regulation
Presentation: Pharmacovigilance: The Australian landscapeTGA Australia
Overview of current post-market monitoring regulations and practice in Australia. Focusing on changing trends and the implications for future post-market vigilance practice.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Similar to European Falsified Medicines Directive (20)
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
2. www.sharpservices.com: Sharp Packaging Services
EU Falsified Medicines Directive
Issued by DG SANCO
- EU Directorate General of Health & Food
Safety
EU Directive 2011/62/EU
- “To reduce the occasions on which falsified
medicines enter the legitimate supply chain”
Contains 4 Delegated Acts
2
3. www.sharpservices.com: Sharp Packaging Services
EU Falsified Medicines Directive
Contains 4 Delegated Acts:
3
FMD
2011/62/EU
Internet
Sales
Good
Distribution
Practice
API
Traceablily
Safety
Features
4. www.sharpservices.com: Sharp Packaging Services
Delegated Act - Safety Features
Timeline:
- Adopted 2nd October 2015
- Published 9th Feb 2016
- Enforced 36 months from approval date
• Exception of Belgium, Italy, Greece
- Applies to all prescription products
manufactured after this date
4
5. www.sharpservices.com: Sharp Packaging Services
Delegated Act - Safety Features
Safety Features will enable wholesale distributors and pharmacists to:
1. Verify the authenticity of the medicinal product
2. Identify individual packs
3. Verify by means of a device, whether the outer packaging has been
tampered with
Compulsory for prescription medicines (with some exceptions)
5
6. www.sharpservices.com: Sharp Packaging Services
Delegated Act - Safety Features
Unique Product Identifier
- 2D Matrix (data carrier)
• GTIN
– 14 digit global product number
• Serial Number
• Lot Number
• Expiry Date
• National Reimbursement No
- Human readable Information.
6
7. www.sharpservices.com: Sharp Packaging Services
Authentication Data Flow
EU Hub managed by
European Medicines
Verification Organisation
A non-profit organisation
7
8. www.sharpservices.com: Sharp Packaging Services
Delegated Act - Safety Features
Tamper Evidence Feature
- Applied on each unit of sale
• Label
• Glue-end
• Over-wrap
• Mechanical closure
8
10. www.sharpservices.com: Sharp Packaging Services
US Drug Quality Security Act
Became law in November 2013
Applies to all prescription drugs with few
exceptions
Enforced from 27th November 2017
Aggregation is not specified but is
expected from major US distributors
10
11. www.sharpservices.com: Sharp Packaging Services
DQSA Title II
Title II:
- Drug Supply Chain Security Act
- “the system will facilitate the exchange
of information at the individual
package level about where a drug has
been in the supply chain.”
11
Drug Quality
Security Act
(Enacted Nov 2103)
Title I:
Compounding
Quality Act
Title II:
Drug Supply Chain
Security Act
Product Tracing
Wholesale,
Distributor & 3PL
Licensing & Stnds
12. www.sharpservices.com: Sharp Packaging Services
US Drug Quality Security Act
12
Major provisions
1. Product tracing
• By lot level – 2015
• By package level 2023
2. Product Verification
• Quarantine & investigation
• Notification & record keeping
3. Product Identification
• Applied to product Nov 2017
Product Identifier consists of:
- National Drug Code
- Serial number
- Lot number
- Expiration date
