This presentation was delivered at the Global Forum 2019 in Africa parallel session on "Production Policies, Laws and Strategies including Trade Barriers" by Hetal Vithlani, Director - Prince Pharmaceuticals Limited, Mwanza (Tanzania).
Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
What are some of the challenges in pharmacovigilance? This presentation offers you more information on signal detection, signal management and risk minimisation measures.
Common Technical Document (CTD) serves as a set of specifications for application dossier for the registration of medicines, and designed to be used across Europe, Japan and the United States. The guidelines for CTD are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). TSDP provides clinical medical writing training on preparation of CTD.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
ISO IDMP: Practical considerations from XEVMPD experienceQdossier B.V.
ISO IDMP (Identification of Medicinal Products) is coming! What lessons can we learn from our practical exprience with XEVMPD in preparation for IDMP? Topics include data cleaning, managing inconsistencies across product registrations and countries and controlled vocabularies
Reconciliation and Literature Review and Signal Detection_Katalyst HLSKatalyst HLS
Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
What are some of the challenges in pharmacovigilance? This presentation offers you more information on signal detection, signal management and risk minimisation measures.
1. A Case report of Heart Failure
2. Discussion on Heart Failure
3. Role of Peptides in Heart Failure
4. Importance of 30 days in heart failure
5. Role of ENTRESTO in Stable Heart Failure patient (PARADIGM-HF study)(HFrEF)
6. Biomarkers in Heart Failure
7. Role of ARNI in Hospitalized Heart Failure patient (PIONEER-HF study)
8. Role of ARNI in HFpEF (PARAMOUNT Trial)
9. Safety and usefulness of ACEI/ARB/ARNI
10. Role of SGPL2 inhibitors in HF with/without DM
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
1. A Case report of Heart Failure
2. Discussion on Heart Failure
3. Role of Peptides in Heart Failure
4. Importance of 30 days in heart failure
5. Role of ENTRESTO in Stable Heart Failure patient (PARADIGM-HF study)(HFrEF)
6. Biomarkers in Heart Failure
7. Role of ARNI in Hospitalized Heart Failure patient (PIONEER-HF study)
8. Role of ARNI in HFpEF (PARAMOUNT Trial)
9. Safety and usefulness of ACEI/ARB/ARNI
10. Role of SGPL2 inhibitors in HF with/without DM
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Signal detection and management activities are at the core of ensuring drug safety. A complex process of signal detection; through their validation and confirmation; analysis and prioritisation; and signal assessment to recommending action.
Find out more at out training: http://bit.ly/1W31NCF
U.S. dependency on foreign pharmaceutical production imposes vulnerability to failure
Authors: Veronika Valdova, D.V.M. and Ronald L Sheckler
Affiliation: Arete-Zoe, LLC
ABSTRACT
Pharmaceutical supply chains have become increasingly complex due to the shift of manufacturing and critical operations to Asia. U.S. pharmaceutical dependency on foreign sole-source production of essential materials imposes vulnerability affecting the entire industry and national health systems from interruption by exposure to natural events and man-made threats, both accidental and criminal as well as political. Sector vulnerabilities stem from complex regulatory landscape, difficulties for enforcement of quality standards at foreign facilities, single-source supply chain resulting from limited sourcing options, increasing shipping distance exposure to both natural events and complicated by maritime chokepoints. Periodic and chronic shortages of many essential products across therapeutic categories have been significant for more than a decade. The Covid-19 crisis aggravated some of these long-standing issues and made the systemic vulnerabilities publicly evident. The combination of limited capacity to exercise control over essential commodities, the long-term trend of outsourcing, with the politicization of business relationships causes the entire pharmaceutical industrial sector to be internationally dependent, creating numerous potentials for systemic failure.
Make In India – Healthcare Reforms, Insurance, Innovations, Investments & Inf...Indian Affairs
7th Annual Pharmaceutical Leadership Summit & Pharmaleaders Business Leadership Awards 2014
Friday, 26th December, Hotel Sahara Star, Mumbai, India
Make In India – Healthcare Reforms
Insurance,Innovations,Investments & Infrastructure
“Empowering India’s Developing Healthcare System”
Investing the Healthcare Solutions of Tomorrow in difficult Times
Make In India – Healthcare Reforms, Insurance, Innovations, Investmentspharmaleaders
7th Annual Pharmaceutical Leadership Summit & Pharmaleaders Business Leadership Awards 2014
Friday, 26th December, Hotel Sahara Star, Mumbai, India
Make In India – Healthcare Reforms
Insurance,Innovations,Investments & Infrastructure
“Empowering India’s Developing Healthcare System”
Investing the Healthcare Solutions of Tomorrow in difficult Times Theme Address : Make In India – Healthcare Reforms, Insurance, Innovations, Investments & Infrastructure.
Mr. Daara Patel, Secretary General, IDMA ( Indian Drug Manufacturers Association)
MTBiz is for you if you are looking for contemporary information on business, economy and especially on banking industry of Bangladesh. You would also find periodical information on Global Economy and Commodity Markets.
Introduction to indian pharma industriespharmacampus
Introduction to Indian Pharma Industries: this highlights leading pharma producers, details of exports of medicines, growth statistics, and high potential generic market.
Export Potentiality of Pharmaceutical goods in BangladeshHr Shamim
The pharmaceutical industry is one of the most dynamic and powerful sectors in Bangladesh. It is technologically one of the most developed manufacturing industries and currently contributes about one percent to total GDP with great potential for expansion. Total domestic healthcare expenditures are currently approximately three percent of GDP, offering substantial opportunity for domestic pharmaceutical sales in addition to exports. The World Trade Organization's (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement permits Bangladesh to reverse-engineer patented generic pharmaceutical products to sell locally and export to markets around the world.
Growth drivers in Indian Pharma Industry pharmacampus
Indian pharma industry growth is driven by Supply Side Drivers, demand-side drivers, and government policy support.
References:
https://www.ibef.org/industry/pharmaceutical-india.aspx
Similar to Overview of Investments in Pharmaceutical Production in Tanzania - Global Forum 2019 in Africa (20)
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
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5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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2. Pharmaceutical Industries in
Tanzania
There are 13 pharmaceutical industries in Tanzania
Only 6 pharmaceutical industries are active :
Mansoor Daya Chemicals Ltd – 1962
Keko Pharmaceuticals Ltd. – 1968 – Privatized (60%) – 1997
Tanzania Pharmaceutical Industry Ltd. – 1977 – Privatized (60%)-1995
Shelys Pharmaceuticals Ltd. – 1984
Zenufa Laboratories Ltd. – 2007
Prince Pharmaceuticals Ltd. – 2017
3. Population of Tanzania
Increase in Population from 10.1 million in 1960
to 55 million in 2018.
Life expectancy has increased from 43 years in
1960 to 62 years in 2018
Urban population has increased from 0.53 million
in 1960 to 14.3 million in 2016 and expected to
grow over 4%.
4. Pharmaceutical market size in
Tanzania
• Pharmaceuticals market in Tanzania is valued at
US $105 million in 2007
• Pharmaceuticals market in Tanzania is valued at
US $457 million in 2016
• Expected growth in next few years is at 10%
5. Opportunities of setting a
pharmaceutical plant in Tanzania
Tanzania is dependant on imported medicine , pharmaceutical products
by 80-85%
Only 15-20% of the total market is covered by the domestic
manufacturers
There are not any manufacturers for medical devices and surgical
textiles e.g. syringes, bandages
85%
15%
6. Benefits contributed by
pharmaceuticals industry sector
1. Has generated direct and indirect employment to
fellow Tanzanian.
2. The Government will generate various taxes e.g.
PAYE, SDL, corporate tax.etc
3. Creates a practical learning area for nearby
universities
4. Creates opportunities for other businesses
5. Increase in access for medicine in both rural and
urban areas at affordable prices
7. Support from the Tanzanian
Government
1. Single Window Registration: One Stop Facilitation through TIC
(Tanzania Investment Centre) for access to various services related to
permits, licenses and approvals.
2. Tax Incentives: 0% taxes and duties on imports of raw and
packaging materials. Capital expenditure in form of pharmaceutical
manufacturing machinery and equipment.
3. Corporate Tax Relief: Corporate Tax reduced to 20% for the first
two years of investment instead of 30% for new investments.
4. Elimination of VAT: Exemption of VAT on packaging and raw
materials produced specifically for use by the local manufactures of
pharmaceutical products.
8. Support from the Tanzanian
government
5. Elimination of various fees and levies: This year the
budget has eliminated 54 types of fees and levies to reduce
the cost of doing business and investment cost in the country
e.g. vaccines and biological USD 150; herbal medicines USD
150
6. TMDA support: Guidance to domestic pharmaceutical
manufacturers to achieve Good Manufacturing Practices
(GMP)
9. MSD Tender Model
•Special Preference for local products : Special
tenders given to domestic manufacturers by
Medical Stores Department for some products that
are being produced locally.
•Price Preference : A preferential margin of 15%
for all locally produced medicines in national
tenders.
10. Emerging Issues/ Barriers
1) VAT on raw materials for newly developed products
suggestion:update the newly submitted list.
2) Permits on importation of raw materials
suggestion:obtain import permits from TMDA only
3)High interest rates on loans
suggestion:provide a special fund with single digit interest
rates to TIB
4)Competition from imported products
suggestion: increase importation fees from 2% to 12% for
products which domestic manufacturers are capable to
produce