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2020 Training Course Schedule

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COURSES RUN BASED ON DEMAND

If no date has been confirmed and you are interested in one of our training courses below, kindly confirm your interest by completing the form at the below.

Professional information for medicines for human use and patient information leaflet training

Date: 5th - 6th February 2020

2 day course

Compilation of the professional information and patient information leaflet:

- LATEST SAHPRA guidelines, covering new PI & PIL format

- South African Legislation, including NEW Regulations to be published

- Overview of Clinical variations 

- General information

- URSNS

- Safety & Medicines Safety Alerts

- Relevance of CCDS & PSURs/ PBRER

- Referencing System

Early bird special: 8 050 (incl. VAT p/p) 

Normal price: R 8 625 (incl. VAT p/p) 

Variations to marketing authorisations in the EU

Date: 26 February 2020

1 day course

- An introduction to the European Commission system for Variations

- The Current Variations Regulations of the EC and procedures in practice

- Review of latest SAHPRA requirements & finalized guidelines

- Pharmaceutical and Clinical Variations
- Practical advice on the preparation and submission of Variation applications

Early bird special: R 4 499 (incl. VAT p/p) 

Normal price: R 4 991 (incl. VAT p/p) 

A Day in the Life of a Regulatory Affairs Pharmacist or Officer

Date: 10 March 2020

Open to ALL BPharm, BSc, BTech graduates and professionals interested in pursuing a career in Regulatory Affairs in the Pharmaceutical Industry

 

1 day course

An introductory course giving an overview of Regulatory Affairs:

- South African Legislation: Medicine Act & Pharmacy Act

- Exposure to SAHPRA & relevant guidelines

- Legal requirements to market medicines in South Africa

- Medicine product filing: Common Technical Dossier
- Medicine product file life-cycle: Variations

- Brief overview of Responsible Pharmacist duties within the pharmaceutical industry

- Quality Assurance/ control

- Inspections

- Pharmacovigilance

- Marketing

Why you should attend?

  • This introductory course is ideally aimed at those that want to gain insight into Regulatory Affairs in the Pharmaceutical Industry.

  • “Get your foot into the door” - Useful for graduates and professionals looking to make a career transition into a new field.

  • Obtain practical exposure to a job within Regulatory Affairs.

Early bird special: R1 999 (incl. VAT p/p) 

Normal price: R 2 499 (incl. VAT p/p) 

All You Need To Know: Pharmacovigilance

Date: 15 - 16 July 2020

2 day course

Topics to be covered over the 2 day course:

  • Overview of ICH & EU pharmacovigilance

  • SAHPRA pharmacovigilance document requirements

  • Pharmacoviligance audits & inspections

  • Periodic Benefit-Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs)

  • Risk Management Plans (RMPs)

  • Roles and responsibilities of a licence holder

  • Post registration ADR Reporting

  • Implications of: Recalls; labelling updates & variations

  • Medicine Safety Alert

  • Standard Operating Procedures (SOPs) related to pharmacovigilance

  • Roles and responsibilities of the person qualified for pharmacovigilance

 

Why you should attend?

  • Gain an understanding of post-marketing pharmacovigilance.

  • Essential information will be covered to aid for those working in pharmacovigilance or entering the field of pharmacovigilance.

  • Capitalise on the opportunity to participate in interactive discussions and exchange experiences with a representative from the SAHPRA Pharmacovigilance Unit & other delegates.

  • Each attendee will receive a course pack containing comprehensive documentation which will be a valuable source of reference.

R 8 500 (excl VAT p/p)

Duties of the Responsible Pharmacist & Deputy Responsible Pharmacist

Date: 18 - 19 August 2020

2 day comprehensive course

• Introduction to Legal requirements for licenses/recordings (SAHPRA/SAPC/ DOH)

• Site Master File

• Overview on:

- Standard Operating Procedures

- Job Descriptions

• Batch Release requirements

• Sales & Marketing

• Pharmacovigilance/Medical Information/Product Queries & Complaints

• Performing a due diligence on a dossier.

• Audits

• Risk management

 

Why you should attend?

• This course is ideally aimed at Responsible Pharmacists in Industry and the Deputy Responsible Pharmacists who require the essential background in order to carry out the RP job function and maintain legal compliance.

• Gain an understanding of the legislation which affect the duties of a Responsible Pharmacist.

• Practical aspects on how to conduct key regulatory functions.

• Opportunity for you to participate in interactive discussions and exchange experiences with other delegates.

R 8 500 (excl VAT p/p)

Medical Devices: Overview of Regulatory Authority Requirements

Date: To Be Confirmed Based on Demand

1 day course

- Medical Devices in South Africa: Legislation, Guidelines, SAMED

- SAHPRA Medical Device Licence Application Compilation

- International Arena - Legislation of Medical Devices: WHO, IMDRF, EMA

- Brief overview - Medical Devices in Other Africa

R 4 340 (excl VAT p/p)

Regulatory requirements of Specific SADC & Other Africa countries

Date: To Be Confirmed Based on Demand

1 day course

Comprehensive training on the regulatory requirements in the following African specific countries:

i.e Botswana, Namibia, Zimbabwe, Zambia, Mozambique, Malawi, Mauritius, Ghana, Nigeria, Kenya, Uganda, Tanzania and Ethiopia.

 

R 6 800 (excl VAT p/p)

Product QC Release by the Pharmacist & Non-Pharmacist: "Ethical" & Complementary Medicine

Date: To Be Confirmed Based on Demand

Half day course

- Release related to regulatory requirements

- Product Batch Document  review

- Certificate of Analysis review

- In-house procedure for release
- Practical examples

R 1 700 (excl VAT p/p)

Marketing Code

Date: To Be Confirmed Based on Demand

1 day course

- Legal Framework

- Marketing Code of Practice

- International Arena on the Marketing of Medicines

- Examples
- Workshop - Regulatory Affairs Compliance

R 4 340 (excl VAT p/p)

Biosimilars vs Generics

Date: To Be Confirmed Based on Demand

1 day course

- Difference between Biosimilars and Generic drug

- Difference between Biosimilars and Biologics

- International arena

- Local requirements

- Practical Application of Guidelines

- Are Biosimilars Interchangeable

R 4 340 (excl VAT p/p)

Inspection readiness

Date: To Be Confirmed Based on Demand

1 day course

Detailing MCC/SAHPRA and SAPC compliance requirements during an audit:

- MCC/SAHPRA and SAPC Legislation

- Legal Compliance during an inspection

- PICS Guideline

R 3 250 (excl VAT p/p)

Comprehensive training on ZA CTD compilation

Date: To Be Confirmed Based on Demand

A 5 day extensive course

An extensive course on ZA CTD compilation Module 1 – Module 5 & submission strategies:

- New Chemical Entities

- Generics

- Complementary Medicines

- Veterinary

R 21 000 (excl VAT p/p)

Company Specific Training

Date: To Be Confirmed (T's & C's apply)

Twinz offers company-specific training. 

Training programmes specially tailored to meet company requirements for groups of ten or more people from the same company. This training is often cost and time effective and aims to improve the productivity of employees.

Kindly contact Salima Mahomed for a quote or more information.

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Course Presenters are

ETDP SETA Accredited 

CONTACT FOR QUERIES:

Salima Mahomed

Tel: 011 852 5252

Mobile: 0826036575

e-mail: training@twinz.co.za or salima.mahomed@twinz.co.za

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DOWNLOADS:

Click icon to download 2019 Course Schedule

All registrations are online.

Click here to register for our current courses.

Interested in attending a Twinz course
Our course dates are based on demand. Therefore, dates are finalised once interested parties confirm interest.
If you are interested in attending any of the courses we offer, please complete form below:

Please tick the box for all courses you are interested in attending:

By clicking submit, you agree to receive email notifications from Twinz.

Once we reach the minimum number of interested delegates, we will confirm a course date and you will be notified via email. However, do keep posted to our website for an update on the courses we run as well as course dates.

Terms and conditions:

Kindly note in order to secure your space, a 50 % non-refundable deposit will be required of the Total amount (course specific) inclusive of VAT.

 

Please note courses will only be held if for:

  • 1 day course; a minimum of 8 attendees register

  •  2-5 day course;  a minimum of 12 attendees register 

      

Cancellation Policy is as stated below, unless stated otherwise:       

The date of the cancellation determines whether the course is still payable, in part or in full, as follows:

  • Cancellation 15 - 30 days prior to the training: 25 % of the course fee shall be due

  • Cancellation 7-14 days prior to the training: 50 % of the course fee shall be due

  • Cancellation less than 7 days prior to the training: the full course fee shall be due

  • No notification of cancellation or failure to attend the training: the full fee shall be due

  • You may also transfer your place in the scheduled course to a colleague if notified a minimum of 3 working days prior to the scheduled course date

NB: Cancellation and transfer of place must be received in writing    

Discounts may be applicable for certain courses and will be applied once the registration is open.

© 2019 Twinz Regulatory Affairs Pharmacist Consultants.

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